Industry News

  • Focused Ultrasound Liver Tumor Treatment Receives CMS Reimbursement

    • The Centers for Medicare and Medicaid Services (CMS) has set a facility procedural payment level of $12,500.50, in addition to the costs associated with single-use devices utilized, for histotripsy of liver tumors.
    • Histotripsy’s novel mechanism of action uses focused ultrasound to mechanically destroy and liquefy targeted liver tissue at sub-cellular levels.
    • HistoSonics is sponsoring ongoing clinical studies in the US and Europe, named #HOPE4LIVER, which are designed to evaluate the safety and technical efficacy of histotripsy in patients with primary and secondary liver tumors.

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  • Meeting Report: Congress of Neurological Surgeons (CNS) Annual Meeting

    • The annual meeting of the CNS was held October 16-20 in Austin, Texas.
    • Focused ultrasound presentations included current indications, clinical trials, and preclinical research.
    • Suzanne LeBlang, MD, presented recent advances in focused ultrasound for treating brain tumors.

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  • Company Profile: IMage Guided Therapy (IMGT, Co., LTD)

    • IMGT is a Korean company that is developing a nanotechnology-based gene and drug delivery system for enhanced immunotherapy solutions.
    • Their portable, ultrasound-guided focused ultrasound device is designed to target several desired treatment areas.
    • Plans are underway to begin clinical trials for treating breast cancer, sarcoma, and pancreatic cancer.

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  • HistoSonics Announces New Procedure Code for Liver Treatment

    • The American Medical Association has issued a new Current Procedural Terminology (CPT®) payment code for histotripsy of the liver.
    • The code is the first for a histotripsy-based focused ultrasound therapy.
    • HistoSonics is conducting clinical trials in the US and Europe to investigate its propriety platform’s ability to destroy liver tumors.

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  • Company Profile: NaviFUS Corporation

    • NaviFUS is a Taiwan-based manufacturer that is developing novel focused ultrasound brain systems.
    • Their devices are currently in human clinical trials for the treatment of brain tumors and epilepsy.
    • Biomechanisms in development include blood-brain barrier opening and neuromodulation.

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  • Company Profile: Neurosona

    • Neurosona aims to develop focused ultrasound for brain treatments, including neuromodulation.
    • Their low-intensity focused ultrasound platform has been used in trials for major depressive disorder and Alzheimer’s disease.
    • The company is headquartered in Seoul, Korea.

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  • Research Funding Available Through the New European Innovation Council

    • The European Innovation Council (EIC) identifies and supports breakthrough technologies and game-changing innovations.
    • The EIC plans to invest €10 billion through 2027.
    • Funding and support are organized into three main tiers for all stages of business.

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  • Act Now: Important New Medicare Reimbursement Pathway Delayed

    • The Medicare Coverage of Innovative Technologies Pathway (MCIT) was set to take effect March 15, but is delayed.
    • The MCIT provides immediate, national coverage for ‘breakthrough’ devices or diagnostics approved by the FDA.
    • We encourage focused ultrasound companies to submit comments in support of the rule.

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  • Cardiawave’s First-In-Human Trial Using Noninvasive Focused Ultrasound for the Treatment of Aortic Stenosis


    Key Points

    • A Research Letter in Circulation details feasibility results from the first 10 patients treated in a clinical trial to soften calcified aortic heart valves.
    • Six participants responded to the treatment, possibly due to a longer duration of therapy.
    • Cardiawave is developing Valvosoft®, an investigational device, not approved for marketing  and not CE-marked, to mechanically soften the hardened valves, improve valve function, and reduce symptoms.

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  • Company Profile: Shanghai A&S


    Key Points

    • Shanghai A&S Science Technology Development Co., Ltd. manufactures and markets diagnostic and therapeutic ultrasound devices in China and internationally.
    • Its tumor ablation device, HIFUNIT9000, is used to treat uterine fibroids and various cancers.
    • This company profile is available in both English and Chinese.

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  • CMS Grants Immediate Medicare Coverage for FDA-Approved Breakthrough Devices

    The Centers for Medicare and Medicaid Services (CMS) has issued a final rule that provides immediate national Medicare coverage for four years for any new device or diagnostic designated as a breakthrough technology and approved by the US Food and Drug Administration (FDA). This new rule – called the Medicare Coverage of Innovative Technologies Pathway (MCIT) – will take place beginning March 15, 2021.

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  • New FDA Program Aims to Expedite Access to Safer Therapies

    The US Food and Drug Administration (FDA) has issued a guidance for its new Safer Technologies Program (STeP), which is designed to facilitate patient access to innovative medical therapies. The program is similar to the Breakthrough Devices Program, which was established in December 2018.

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  • Company Profile: Precision Acoustics, Ltd.

    Precision Acoustics, Ltd. (PA) is a United Kingdom—based original equipment manufacturing company that designs and manufactures the tools that measure the ultrasonic pressure, intensity, and range of focused ultrasound systems.

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  • Company Profile: TOOsonix

    TOOsonix A/S is a focused ultrasound company based in Hørsholm, Denmark. Founded in 2017, its first device was recently released in the European Union for aesthetic applications, and dermatology studies are ongoing for treating skin cancer. We interviewed one of its founding directors, Torsten Bove, MS, to learn more.

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  • Company Profile: PI Ceramic

    Focused ultrasound companies rely on equipment manufacturers to provide the high-tech, high quality components when building their transducers and peripheral systems. PI Ceramic is a German company that fabricates one of the most critical parts of a focused ultrasound – or any type of ultrasound – machine: the piezoceramic elements that vibrate to produce the ultrasound. We interviewed Annemarie Oesterle, Segment Marketing Manager Medical Technology at PI Ceramic to learn more about this dynamic company.

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  • Associated Industries: Microbubble Manufacturers

    Today, the Foundation is aware of 86 companies that contribute equipment or supplies to the focused ultrasound industry. The list is divided into four categories: Device Manufacturers, Distributors, Microbubble manufacturers, and Original Equipment Manufacturers (OEMs).

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  • Industry Overview: Focused Ultrasound’s Original Equipment Manufacturers

    stock oem manufacturingToday, the Foundation is aware of 86 companies that contribute equipment or supplies to the focused ultrasound industry. The list is divided into four categories: Device Manufacturers, Distributors, Microbubble manufacturers, and Original Equipment Manufacturers (OEMs).

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  • US Manufacturers Can Apply for Loans Under the Paycheck Protection Program

    Because the COVID-19 crisis is significantly impacting many focused ultrasound companies, we want to make you aware of some important resources that may help.

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  • Two Manufacturers Recap 2019 Highlights and Look Forward

    TheraclionFrench manufacturer Theraclion credits notable fundraising in 2019 with allowing the company to focus on distribution of their SONOVEIN® device to treat varicose veins. The device earned CE marking in April, and the company says it is working toward an FDA approval for SONOVEIN in 2021.

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  • Company Profile: Pro-HITU

    Shenzhen PRO HITU Medical Co., LTD., is an international, high-tech Chinese research and development company founded more than 15 years ago that builds ultrasound-guided focused ultrasound systems. Initially launching their devices in the treatment of uterine fibroids, the company is looking toward a future of treating other types of tumors, such as those that cause pancreatic cancer. We recently interviewed Pro-HITU’s co-founder and CEO, George Zhang, to learn more.

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  • Sonic Concepts Develops Novel, Customized Platform for Neuromodulation

    Sonic Concpets Inc clrUnder the branding of “NeuroFUS™,” Seattle-based Sonic Concepts, Inc. has developed strategic partnerships with software and distribution companies to further expand its ability to provide custom technology solutions to researchers - now in the area of focused ultrasound neuromodulation. We interviewed company President, Kyle Morrison, to learn more.

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  • Company Profile: Cardiawave

    With the encouraging completion of a first-in-human feasibility study, French manufacturer Cardiawave presented results from the first 10 patients at large cardiovascular meetings. This innovative start-up’s current clinical trial uses their Valvosoft platform and a completely noninvasive focused ultrasound technique to address aortic heart valve stenosis (narrowing) caused by calcification of the valve leaflets.

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  • Company Profile: Bracco

    Bracco is one of the world’s leaders in diagnostic imaging. The Bracco Suisse Research Centre was founded in 1989 in Geneva from the spin-off of a research team of The Battelle Institute. Since 2010, the Centre has been devoting its efforts with an efficient process-oriented approach and has achieved a track record of innovations in the ultrasound field. The Bracco Geneva site, which houses both the R&D and Manufacturing Units, represents a key asset for the Bracco Group and a reference point at international level.

    Thierry Bettinger, PhD, Bracco Research Center Geneva Director at Bracco Suisse SA, Switzerland. We recently spoke with Dr. Bettinger about this innovative company. 

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  • Insightec Device Compatible with SIGNA Premier MR System

    Insightec’s Exablate Neuro device has earned FDA approval and CE mark to be used with GE Healthcare’s most powerful wide-bore 3.0T device, the SIGNATM Premier MRI System.

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  • Industry and Advocacy Leaders Advise HHS on How to Accelerate Clinical Innovation

    On June 20, the US Department of Health and Human Services (HHS) hosted a public hearing in Washington, DC, to seek input from a variety of stakeholders on their "ReImagine HHS: Accelerate Clinical Innovation" initiative.

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  • New CPT Code Established for EDAP’s Focal One Prostate Cancer Treatment

    In a June 10 announcement, EDAP-TMS shared positive news with regard to the billing and reimbursement of their Focal One high-intensity focused ultrasound (HIFU) treatment for prostate cancer. After submitting an application to the American Medical Association (AMA) CPT® Editorial Panel and gaining the support of both the American Urological Association and the American Association of Clinical Urologists, the company has been notified that the AMA established a new Category 1 CPT code* for HIFU ablation of malignant prostate tissue with their Focal One device. The code, which will be described as "ablation of malignant prostate tissue, transrectal, with high intensity focused ultrasound (HIFU) including ultrasound guidance," goes into effect on January 1, 2021.

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  • Meeting Report: International Society for Therapeutic Ultrasound & European Focused Ultrasound Charitable Society Joint Meeting

    The joint meeting of the International Society for Therapeutic Ultrasound (ISTU) and the European Focused Ultrasound Charitable Society (EUFUS) was held in Barcelona from June 13-15, 2019. The Foundation supported the meeting, which was ISTU’s 19th Annual International Symposium for Therapeutic Ultrasound and the 5th European Symposium of EUFUS. The meeting drew over 480 international participants from 33 counties with an interest in therapeutic focused ultrasound applications. Several representatives from the Focused Ultrasound Foundation participated in the program, met with industry representatives, and formed numerous collaborations. Foundation Chairman Neal F. Kassell, MD, spoke during the Horizon/Jolesz Lecture, and Director of Clinical Relationships, Suzanne LeBlang, MD, participated in a panel.

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  • Meeting Report: 2019 Society for Image-guided Neurointerventions

    More than 85 neuroradiologists, neurosurgeons, neurologists, oncologists, and scientific researchers attended the 2nd meeting of the Society for Image-guided Neurointerventions (SIGN) held June 10-11 in Baltimore, Maryland. Co-sponsored by the Children's Brain Tumour Drug Delivery Consortium, the conference included daily live webinars covering clinical perspectives on drug delivery to the brain and technological advances along with its general sessions.

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  • Meeting Report: European Society for Hyperthermic Oncology 2019

    ESHO, the European Society for Hyperthermic Oncology, held their annual meeting in Warsaw, Poland, from May 22-24, 2019. The conference is centered on clinical hyperthermia, which is commonly achieved with deep regional radiofrequency (RF) heating and either local sensor-based temperature monitoring, or, more recently, noninvasive MRI-based temperature monitoring. In this context, hyperthermia means heating tumor tissue to a temperature range of 41 to 43 degrees C to sensitize the tissue to both radiation and chemotherapy and make these treatments more effective. Alternatively, hyperthermia could be used to trigger local drug release from temperature-sensitive drug carriers, such as liposomes.

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  • Meeting Report: Society for Thermal Medicine (STM) Annual Meeting

    The annual meeting of the Society for Thermal Medicine (STM) was held April 28 – May 2 in St. Pete Beach, Florida. The international event attracted more than one hundred attendees from engineering, physics, materials science, and biology.

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  • Meeting Report: Regulatory Education for Industry (REdI)

    On May 29-30, two offices in the US Food and Drug Administration – the Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) and the Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE)-- collaborated to hold an interactive workshop with the FDA’s regulatory experts. The course, titled Regulatory Education for Industry (REdI), provided participants with a basic foundation for understanding the FDA’s drug and medical device regulatory requirements. The following recordings from the devices track are now available:

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  • Preprints Survey

    As part of a grant* from the Alfred P. Sloan Foundation, the Center for Open Science (COS) is asking for graduate students, post docs, faculty at research institutions, and other researchers to participate in a survey to investigate the factors that affect the perceived credibility and use of preprints. Preprints are research papers that are openly shared prior to the peer review process. The survey will assess use and credibility of preprints across scholarly domains. Anyone is welcome to take the survey.

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  • Essential Tremor Position Statement Published by the American Society for Stereotactic and Functional Neurosurgery

    The American Society for Stereotactic and Function Neurosurgery (ASSFN) recently published a new position statement on the use of focused ultrasound for the management of patients with essential tremor.

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  • Prostate Cancer Trial Results Announced

    Profound Medical announced the final results from their TULSA-PRO ablation clinical trial (TACT) in patients with prostate cancer at the annual meeting of the American Urological Association (AUA), which was held May 3-6, 2019, in Chicago. The pivotal study was designed to support Profound’s FDA application to market the device in the United States, and the results show that the study met or surpassed all primary safety and efficacy endpoints.

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  • Meeting Report: American Urological Association 2019 Annual Meeting

    The annual meeting of the American Urological Association (AUA) was held May 3-6 in Chicago. Fourteen scientific abstracts featured high-intensity focused ultrasound (HIFU) technology for prostate and kidney applications, with many studies comparing HIFU to other treatment options. One significant highlight was Profound Medical’s presentation of the final data from their TULSA-PRO Ablation Clinical Trial (TACT).

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  • Theraclion Obtains CE Mark for Treatment of Varicose Veins

    In April, Theraclion announced that it had obtained the CE Mark for its newly developed SONOVEIN® focused ultrasound system for the treatment of varicose veins.

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  • Meeting Report: American Association of Neurological Surgeons

    The 87th Annual Scientific Meeting of the American Association of Neurological Surgeons (AANS), which was held in San Diego, California, on April 13-17, 2019, was an excellent opportunity to highlight progress in the focused ultrasound field. More than 2,000 neurosurgeons from around the globe attended the conference, making this one of the highest profile meetings in the clinical neurosciences.

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  • Mirabilis Medical Names Wayne Poll New CEO

    Mirabilis Medical, Inc., the developer of a noninvasive therapeutic ultrasound system with an initial application for the treatment of uterine fibroids, appointed Wayne Poll, MD, as their new CEO.

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  • Company Profile: CarThera

    With new clinical trial results published and a follow-up study now underway, CarThera is making strides in treating patients with serious brain tumors. We interviewed their Scientific Director, Michael Canney, PhD, to learn more about this dynamic company.

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  • Meeting Report: American Association of Cancer Research 2019 Annual Meeting

    Scientists and physicians from around the world met at AACR 2019 in Atlanta, Georgia from March 29 to April 3 to learn about the latest discoveries across the spectrum of cancer research. The meeting covered a wide range of topics, including population science, prevention, cancer biology, translational and clinical studies, and survivorship and advocacy. This annual conference highlights the best international work in research and medicine.

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  • FDA and National Brain Tumor Society Sponsor Brain Metastases Workshop

    On March 22, the Foundation’s Director of Clinical Relationships, Suzanne LeBlang, MD, and more than 250 researchers, industry professionals, and patients attended a day-long workshop titled “Product Development for Central Nervous System (CNS) Metastases,” which was co-sponsored by the US Food and Drug Administration (FDA) and the National Brain Tumor Society.

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  • New Trial Results: Blood-brain Barrier Opening May Facilitate Drug Delivery for Glioblastoma

    French medical device start-up CarThera recently published the complete results from its Phase I/IIa clinical trial using the SonoCloud-1 ultrasound implant to open the blood-brain barrier (BBB) prior to carboplatin chemotherapy in patients with recurrent glioblastoma (GBM).

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  • Meeting Report: Matsumoto Honored at SIR 2019

    Last month, interventional radiologists gathered in Austin for the Society of Interventional Radiology (SIR) 2019 Annual MeetingAlan H. Matsumoto, MD, FSIR, Chief of Radiology at the University of Virginia Health System and Clinical Director of the UVA Focused Ultrasound Center, was chosen to present the 35th Annual Charles T. Dotter Lecture. This award is selected by the SIR president based on extraordinary contributions to the field, dedicated service to the society, and distinguished career achievements in interventional radiology. 

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  • Foundation, Sonic Concepts, and Verasonics Partner on Preclinical Research Platform

    The Foundation has signed a Research Funding Agreement with two well-known companies in the focused ultrasound industry to develop a turnkey ultrasound-guided preclinical research system.

    Verasonics logoVerasonics, a leader in research ultrasound, and Sonic Concepts, Inc., an innovator of high-performance transducers, will work to expand the HIFUPlex Portfolio into systems that can treat both large and small animals. The new devices will offer 3D positioning, planning, and therapy delivery as well as therapy monitoring. The Foundation will advise the two companies on device usability and software applications. 

    Leading the project from the Foundation’s team will be John Snell, PhD, Technical Director of the Brain Program, and Frederic Padilla, PhD, our current Richard Merkin Scholar and associate professor at the Laboratory of Therapeutic Applications of Ultrasound in Lyon, France.

    SonicConcepts logo“Introducing a turnkey preclinical system can transform early focused ultrasound research,” said Snell. “To date, much of the preclinical research in the field has been using custom devices created by engineers at each site. This type of device can enable clinicians who are interested in preclinical research to create labs quickly without the hurdle of creating their own system. I also hope it will help standardize research so that we can easily compare data from multiple sites knowing that the same device was used.”

    “Ultrasound-guided focused ultrasound has become an exciting tool to treat or manage different medical conditions for improved outcomes,” said Jessica L. Foley, PhD, the Foundation’s Chief Scientific Officer. “We are looking forward to teaming up with Verasonics and Sonic Concepts on this compelling and important research project.”

    Read the Press Release from Verasonics and Sonic Concepts >


    Related News
    Company Profile – Sonic Concepts June 2018
    Focused Ultrasound Featured at CES – The World’s Largest Showcase of Technology and Innovation January 2018
    Seattle Collaboration Creates HIFUPlex, a New Research SystemJune 2017
    Company Profile – Verasonics Develops Flexible, High Tech Ultrasound for Research November 2016
    Company Profile – Sonic Concepts January 2015

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  • Company Profile: EDAP TMS

    EDAP TMS is a French company specialized in focused ultrasound treatment of the prostate. In 2015, the US Food and Drug Administration approved their Ablatherm® Robotic HIFU device, and their Focal One® device earned approval earlier this year. We recently interviewed three members of the company’s leadership: Emmanuel Blanc, Director of Research & Development; Vincent Mortureux, HIFU Product Manager; and Maude Pavageau, Communications Manager.

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  • Insightec Partners with Virginia Tech for Brain Research, Closes $150 Million Series E Funding Round

    In a partnership facilitated by the Foundation, Insightechas selected Virginia Tech’s Carilion Research Institute (VTCRI) as its first nonclinical research site for developing new treatment options for brain disorders. VTCRI scientists will use Insightec’s Exablate Neuro system paired with a Siemens MRI unit to study potential applications for attacking brain tumors, opening the blood-brain barrier to deliver therapeutics, and treating psychiatric disorders using FUS-induced neuromodulation.

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  • Meeting Report: AAPM 2017

    AAPM 2017 Logo Square Final 01The American Association of Physicists in Medicine (AAPM) held their annual meeting from July 30 through August 2 in Denver. The focused ultrasound presentations covered topics ranging from the history of cancer immunotherapy and the role FUS can play in immunomodulation; clinical case studies in the use of FUS for the treatment of bone tumors and movement disorders; and the development of new FUS devices for brain treatments. “Many of the clinicians who attended this meeting share our views on open science and collaboration,” said the Foundation’s Director of Extramural Research, Matt Eames, PhD, after attending the sessions. “I was pleased to hear how the principles that are permeating our work at the Foundation (and other medical not-for-profit organizations) are also being advocated in the medical physicist community.”

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  • Raising Awareness about Essential Tremor among Consumers

    The Foundation recently spoke with Rick Schallhorn, Vice President of Neurosurgery, and Xen Mendelsohn Aderka, Vice President of Marketing, for Israel-based Insightec, the company behind focused ultrasound technology for essential tremor (ET). They share their efforts to increase awareness for the focused ultrasound treatment for ET.

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  • Advancing Focused Ultrasound for Movement Disorders

    Insightec’s Exablate Neuro is approved in the US, Canada, Europe, Israel, Korea, Japan, and Russia for the treatment of essential tremor. It is also "CE marked" (a manufacturer’s indication that a product conforms with relevant legislation applicable to their product and therefore is permitted for use) to treat Parkinsonian tremor and neuropathic pain. Researchers around the world are working to assess the system in the treatment of several other related movement disorders.

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  • Company Profile: Mirabilis Medical

    On the heels of their recent CE Mark announcement, we spoke with Mirabilis Medical’s CEO, Jens U. Quistgaard, to learn more about the company, its device, and what’s on the horizon. “This technology has the promise of helping a large number of women worldwide, and I’m glad to be involved with it,” says Quistgaard. 

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  • Mirabilis Medical Awarded CE Mark for Uterine Fibroids

    Mirabilis Medical has been granted European CE Mark approval to begin marketing their robotically assisted non-invasive focused ultrasound system to treat uterine fibroids. This milestone was accomplished after the company completed their first clinical trial, safely and successfully treating 73 women in Mexico with an average active treatment time of less than 10 minutes each.

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  • NaviFUS Executives Visit Foundation

    NaviFUS logo 180Executives from NaviFUS, a new focused ultrasound company in Taiwan, visited the Foundation to share information on the status of their company and their plans to begin clinical trials. Company Chairman, Chiu S. Lin, PhD, and CEO, Ming-Che Wang, PhD, were joined by Neurosurgeon Kuo-Chen Wei, MD, and Professor Hao-Li Liu for meetings at the Foundation and the University of Virginia. 

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  • Verasonics Develops Flexible, High Tech Ultrasound for Research

    Seattle Area-based Verasonics designs and develops a programmable research ultrasound platform that optimally combines energy application and image monitoring all in one for focused ultrasound (FUS) research, development, and commercialization. In addition to therapy, Verasonics’ research ultrasound systems are used for investigation in novel imaging techniques, physics, materials testing, education, and other applications.

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  • Medicare Establishes Payment Level for Treatment of Tremor

    The Centers for Medicare and Medicaid Services (CMS) has set the institutional payment for focused ultrasound treatment for essential tremor at approximately $10,000. After two years CMS will reevaluate the payment level based on the actual costs of treatments performed during that interval.

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  • EpiSonica Gains Regulatory Approval in Taiwan

    Taiwan-based EpiSonica has secured Taiwan Food & Drug Administration (TFDA) clearance of its ArcBlate MR-guided focused ultrasound system for soft tumor ablation of uterine fibroids, adenomyosis, and palliative pain care. ArcBlate can be used in any commercial MRI system.

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  • Profound Earns European Approval for Prostate Device

    Profound Medical’s TULSA-PRO™, a real-time, MRI-guided, minimally invasive focused ultrasound device, was granted CE approval on April 11 for the commercial sale in Europe and in other CE Mark jurisdictions.

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  • FUS Poised for Growth in Japan

    After nearly 20 years of activity in the country, focused ultrasound may now be positioned for commercial success in Japan.

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  • Translation and Commercialization Flourish at the University of Washington

    Eight years ago, focused ultrasound pioneer Larry Crum, PhD, transitioned away from directing the department that houses the focused ultrasound efforts at the University of Washington (UW), but under the leadership of Tom Matula, PhD, it has continued to grow into a powerhouse for researching and commercializing focused ultrasound technologies.

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  • Profound Partners with Philips for Prostate

    As announced this summer by Philips and Toronto-based Profound Medical, the two companies will integrate Profound’s TULSA (Transurethral Ultrasound Ablation) technology onto Philips’ 3T MRI systems. TULSA is designed to provide minimally invasive, single session whole gland ablation for patients with prostate cancer.

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  • Canadian Government Agency Deems FUS as Cost-Effective, Least Invasive Treatment Option for Fibroids

    The Ontario Health Technology Advisory Committee (OHTAC) has recommended focused ultrasound (FUS) as a possible “cost-effective strategy” and a “safe and effective, noninvasive, uterine-preserving” option for women seeking treatment for uterine fibroids.

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  • EDAP Changes U.S. Regulatory Strategy

    EDAP-TMS is changing their US regulatory strategy to pursue direct De Novo 510(k) approval for their Ablatherm systemto treat prostate cancer instead of continuing to pursue a Pre-Market Approval (PMA) application. The company made this decision based on discussions with the US Food and Drug Administration (FDA).

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  • Company Profile: Sonic Concepts

    During the recent visit from Sonic Concepts’ Founder and President, George Keilman, we asked about the creation, technological advancements, and new applications of the company.

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  • Important Meetings for Your 2015 Calendar

    As we begin the new year, we encourage you to mark your calendars for these important meetings.

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  • EDAP Receives FDA Guidance for Ablatherm

    EDAP-TMS received a letter from the US Food and Drug Administration (FDA) indicating that, although their premarket application for the Ablatherm device to treat localized prostate cancer was not approvable in its current form, a path forward is possible.

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  • FUS Experts Believe Brain and Cancer Applications Have Most Potential to Improve QOL

    The Foundation conducted a survey of 150 members of the focused ultrasound community on the state of the field prior to the October 2014 Symposium.

    Respondents were asked to identify which clinical indications were most likely to improve patients’ quality of life. Neurological and oncological indications are tied for the most votes, with brain tumors, essential tremor, and pancreatic cancer being rated as the top three individual indications. Similarly, respondents were asked to rank the top three bioeffects that are most likely to have long-term therapeutic value. Thermal ablation is ranked first, followed by drug delivery and neuromodulation.

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  • Elekta’s Executive Director Shares Insight, Praises the Role of the Focused Ultrasound Foundation

    Tomas Puusepp, Executive Director of the Board of Elekta and its former CEO, recently visited the Foundation and shared his experience in providing an emerging technology (the Gamma Knife) to the patients who need it. His thoughts on taking risks, competition, and overcoming barriers provide many valuable insights that apply to focused ultrasound.

    When Puusepp joined Elekta in 1988, it was a $5 million company with a staff of 22—today it has $1.5 billion in revenue and 4,000 employees. With a background in electrical engineering and physics, he advanced through the management ranks within Elekta to serve as President and CEO from 2005 through April 2014.

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  • Company Profile: Philips Healthcare

    This month, we highlight the company behind the new focused ultrasound Center of Excellence (COE) in London: Philips Healthcare. Thanks to Philips’ generous support and impressive scientific vision, the COE is established at the Institute for Cancer Research (ICR) at The Royal Marsden Hospital’s Sutton, Surrey site and will advance focused ultrasound treatment of cancer.

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  • The Institute of Cancer Research and The Royal Marsden Celebrate Opening of Focused Ultrasound Center of Excellence in London

    The first clinical trial has begun at the new Focused Ultrasound Foundation Center of Excellence (COE) at the Institute of Cancer Research, London. This center is a public-private collaboration between the Foundation, The Institute of Cancer Research (ICR), Philips Healthcare, and The Royal Marsden NHS Foundation Trust to create a state-of-the-art resource for clinicians and scientists to develop clinical evidence and establish best practices, treatment standards, and protocols for the use of focused ultrasound to treat cancer.

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  • Commentary: Putting the FDA Panel’s Feedback Into Perspective

    Last month, the FDA advisory panel made a highly unfortunate ruling that, based on data presented by EDAP, there is not reasonable assurance that the Ablatherm focused ultrasound device is safe and effective for the treatment of low risk localized prostate cancer. The device has been approved in Europe since 1999, and 40,000 patients around the world have been treated with the system to date.

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  • FDA Advisory Panel Votes Against Approval of Prostate Device

    The following article appeared on Medscape.com. View the original story here.

    A US Food and Drug Administration (FDA) advisory panel voted yesterday not to recommend approval of a high-focus ultrasound technology to treat low-risk prostate cancer with less erectile dysfunction.

    The technology, Ablatherm Integrated Imaging High Intensity Focused Ultrasound (HIFU), has been used in other countries in 40,000 patients for 15 years. It would be the first device of its kind to be approved in the United States.

    But members of the Gastroenterology and Urology Panel of the FDA's Medical Devices Advisory Committee voiced a range of concerns about lack of data available from the technology sponsor's research results that were presented as part of its US premarket approval (PMA) application. HIFU is marketed in Europe by EDAP TMS, a French company operating in the United States as EDAP Technology.

    The company is seeking premarket approval for HIFU as indicated for primary treatment of individuals with low-risk, localized prostate cancer.

    In the end, a majority of panel members voted no to the question regarding a reasonable assurance that the treatment is safe. Panel members voted unanimously against reasonable assurance that it is effective.

    HIFU is a robotic technology that consists of a treatment module that connects a control console to an endorectal probe device. After a patient is anesthetized, aurologist robotically controls the probe for insertion into the rectum, and the device delivers ultrasonic energy to a focused portion of the prostate.

    High-intensity waves from an ultrasound imaging transducer in the probe generates intensive heat (85° - 95° C) and causes ablation of cancerous tissue while preserving the apex, sphincter, and rectum, with a lower rate of erectile dysfunction.

    Rocky Path

    A rocky regulatory path developed almost from the start, however, for HIFU in the United States. A nonrandomized trial intended to be a pivotal study that began in 2006 to test HIFU against cryotherapy terminated in 2010 because of the company's inability to enroll enough patients, particularly for cryotherapy.
    EDAP then conducted a meta-analysis of HIFU and cryotherapy results in the medical literature, plus a review of comparisons of a European HIFU registry with surgery in the US Veterans Administration study Prostate Cancer Intervention vs Observation Trial (PIVOT).

    EDAP presenters at the hearing said the "body of evidence" supports the approval of HIFU in the United States. They said that the benefits of a noninvasive, localized therapy with precise energy delivery outweigh the risks for urinary obstructive morbidity and that side effects from HIFU treatment are "not dissimilar" to those of other prostate cancer treatments, including radiation therapy.

    FDA presenters, however, went through EDAP's submission documents point by point, citing deficiencies, such as lack of information and potential safety concerns, including a 28% cumulative positive biopsy rate 2 years after HIFU treatment among individuals in the nonrandomized trial.

    Regarding the lack of information, Johathon P. Jarow, MD, of the FDA's Office of Hematology and Oncology Products, said, "Absence of evidence is not the same as evidence of absence," and that it was not clear whether HIFU treatment is better than doing nothing for the low-risk patients.

    Unclear Effectiveness

    The treatment does have its supporters, though. In the public hearing portion of the meeting, Pascal Rischmann, MD, professor and chair of urology, andrology, and renal transplant at Université Paul Sabatier in Toulouse, France, said that the treatment is safe and effective, that it preserves erectile function in more than 90% of patients through nerve sparing, and that it is cost- effective. He said he has used HIFU in more than 350 patients between 2006 and 2014.

    Prostate cancer survivors also recommended approval during the public hearing.

    Inderbir Gill, MD, chair of the University of Southern California, Los Angeles, Institute of Urology, and a monitor of the HIFU trial, told panel members that HIFU is certaintly not perfect but that all ablation technologies have similar biopsy rates.

    "It's about patient choice," he said. He pointed out that HIFU has a track record of 40,000 patients during a 15-year period and that it has never been suspended or taken off the market.

    But the FDA officials maintained that the benefit of HIFU is unclear and that the risk is substantial, although they acknowledged that EDAP's efforts had been constrained by practical difficulties associated with conducting trials for prostate cancer.

    Stephen R. Kraus, MD, of the University of Texas Health Science Center in San Antonio and a temporary voting member, said he was concerned about the "murkiness" of the data, or "trying to use other trials to make up for the lack of recruitment. Murkiness is the absolute reason we need a controlled trial."

    Consumer representative Mildred D. Fennal, PhD, RN, of the International Nurses Education Consortium in Tallahassee, Florida, said, "If anything, it sounds like they're trying to save all the work that's been done" and that maybe they should have reorganized early on and tried something else.

    The advisory committee members have disclosed no relevant financial relationships.

     

    View EDAP's official press release. Documents provided at the meeting will soon be available as well on their website

    View more coverage from Bloomberg.

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  • Foundation’s Unique Partnership Showcased

    The Foundation’s chairman, Dr. Neal F. Kassell, delivered the keynote speech at the BIRD (United States-Israel Binational Industry Research & Development) Foundation’s Reception at the United States Chamber of Commerce on June 25. Addressing a room of decision makers from Washington and Israel, Kassell shared the story of focused ultrasound technology in neuroscience and next steps for essential tremor research.

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  • Company Profile: Theraclion

    Celebrating its 10th anniversary this year, Theraclion is a French focused ultrasound company that currently specializes in treating benign breast tumors and thyroid nodules. Their Echopulse system is approved in Europe and available to patients in France, Italy, and Germany. With the start of their first U.S. clinical trial and the recent news that the company has become publicly traded, we interviewed Chief Technology Officer Sylvain Yon, PhD, to discover more about the company’s accomplishments, status, and future direction. Sneak peak: Their ultimate goal is to noninvasively treat every kind of tumor. 

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  • Reimbursement Summit Attendees Create Action Plan for Fibroids and Bone Pain Palliation

    In an example of the power of collaboration, the Foundation hosted a Reimbursement Summit on May 13th in Charlottesville. The more than 20 attendees included professionals from Philips Healthcare, InSightec, EDAP-TMS, and reimbursement consulting firm ADVI. The group attained their primary objective to develop an integrated action plan to obtain U.S. reimbursement for focused ultrasound treatment of uterine fibroids and palliation of painful bone metastases.

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  • Company Profile: HistoSonics

    HistoSonics, Inc. is a Michigan-based company that is using the non-thermal histotripsy mechanism of focused ultrasound to treat benign prostatic hyperplasia (BPH). Although BPH causes an enlarged prostate, it does not lead to cancer-the unwanted cells need to be removed when they cause irritation or obstruction. VortxRX is the company's investigational, image-guided, system for treating BPH. A pilot clinical trial is currently underway in North America to test the system’s safety and initial effectiveness.

    Q&A With HistoSonics Chairman & CEO Tom Davison, PhD

    Q. How did you get involved in starting HistoSonics?

    I was introduced to the University of Michigan (UM) Department of Tech Transfer in late 2007. UM asked me to help evaluate several medical device technologies in their patent portfolio, including histotripsy. Because of my experience in therapeutic ultrasound businesses (UltraCision and Sontra), UM asked me to review the histotripsy program to determine whether it should be licensed or had the potential to support a stand-alone business. At the completion of the consulting assignment, I acquired an option to license the histotripsy technology and intellectual property. After several years of planning, HistoSonics was founded in December 2009.

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  • Washington-Russian Collaboration Sends Shock Waves Through Focused Ultrasound

    An alternative method of tissue fractionation--boiling histotripsy--has been developed in a unique collaboration between and the University of Washington (UW) in Seattle and Moscow State University (MSU) in Russia. Drs. Vera A. Khokhlova, Lawrence A. Crum, and the growing UW/MSU teams have developed the method that uses longer (millisecond instead of microsecond) duration focused ultrasound pulses to generate a millimeter-sized boiling bubble (instead of a cavitation cloud) through tissue heating by shocks. Two papers that detailed their groundbreaking work were published in Ultrasound in Medicine and Biology and the Journal of the Acoustical Society of America.

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  • International Society for Therapeutic Ultrasound 14th Annual Symposium Highlights Latest Advances in Non-Invasive Focused Ultrasound Technology

    ISTU Release Photos mdApril 15, 2014 -- Charlottesville, VA – Presentations at the recent symposium of The International Society for Therapeutic Ultrasound (ISTU) demonstrate an increasing body of data supporting the potential of focused ultrasound to transform the treatment of a wide range of diseases. This early-stage, non-invasive technology could be a cost-effective alternative or adjunct to traditional surgery, radiation therapy, and drug delivery to treat conditions such as brain tumors, movement disorders, prostate cancer, and soft tissue tumors. Currently approved in the U.S. for the treatment of uterine fibroids and painful bone metastases, many healthcare experts consider focused ultrasound a disruptive technology to watch.

    “Focused ultrasound is increasingly being considered a game-changing technology,” said Kim Butts Pauly, Ph.D., ISTU 2014 Committee Chair and Professor of Radiology, Stanford University School of Medicine. “We are excited to host researchers from many disciplines around the world -- including medical physics, engineering, biomedical science, radiology, oncology, and neurosurgery -- to share significant pre-clinical and clinical progress being made with focused ultrasound.”

    Promising Data Expands the Frontiers of Focused Ultrasound

    The range and depth of scientific presentations at the 2014 ISTU meeting demonstrate the broad applicability of this platform technology to produce multiple biological mechanisms. Focused ultrasound can have therapeutic effect both directly by ablating unhealthy tissue or dissolving blood clots and indirectly, such as by opening up the blood-brain barrier to allow the delivery of therapeutic agents.

    “It is critical that the next phase of innovation in focused ultrasound optimizes the potential to treat the most urgent medical needs that will benefit the greatest number of patients,” said Neal F. Kassell, chairman of The Focused Ultrasound Foundation, a major sponsor of the conference. “One revolutionary approach involves using the technology to non-invasively treat problem areas deep in the brain, while bypassing healthy brain tissue and preserving normal functions. The successes in movement disorders point to a very promising future for this powerful tool.”

    Presentation Highlights

    Several new clinical studies were presented at the symposium, including the following highlights:

    Uterine Fibroids

    In-Office Rapid Volumetric Ablation of Uterine Fibroids Under Ultrasound Imaging Guidance: Preclinical And Early Clinical Experience With The Mirabilis Trans-Abdominal HIFU Treatment System

    Jessica Parsons, Ph.D., Clinical Science Manager at Mirabilis Medica, Inc. presented results of a single-arm pilot study of 37 women treated with their experimental focused ultrasound system prior to hysterectomy. The treatment was delivered using ultrasound imaging guidance with no skin burns or collateral tissue injury. No anesthesia or sedation was required in a large majority of patients. The average total treatment time was 4.9 minutes. This dramatically shorter treatment time was achieved using a shell ablation technique, which involves focusing the ultrasound energy on the outer surface of the target volume to allow thermal and ischemic effects to work in concert. The average non-perfused volume created in the study ranged between 0.6 and 51.3 cc, depending on the treatment parameters used.

    Clinical Application of High-Intensity Focused Ultrasound Ablation in Gynecology: Safety Analysis

    Lian Zhang, M.D., of Chongqing Medical University in China presented a seven-year study evaluating the safety of focused ultrasound treatment of more than 10,000 patients with uterine fibroids or adenomyosis at 10 centers in China. The treatments were very effective, with an average of 80% non-perfused fibroid volume achieved. The treatments were safe, with 13.15% of patients experiencing anticipated minor side effects immediately after the procedure (abnormal vaginal secretion, lower abdominal pain, transient leg or buttock pain, dysuria, vomiting, uterine bleeding, urinary retention or fever). Longer-term side effects (skin blisters, leg or buttock pain, and uterine bleeding) occurred in 0.12%. Major complications, which have previously led to substantial morbidity and disability, did not occur in this study.

    Soft Tissue Tumors

    Treatment of Extra-Abdominal Desmoid Tumors Using MR-Guided High Intensity Focused Ultrasound: Preliminary Results after Five Patients

    Pejman Ghanouni, M.D., Ph.D., Stanford University, shared his experience treating 5 patients with desmoid tumors, rare aggressive benign growths that affect young adults. Five patients with a median age of 17 years were treated. The average treatment time was 4 hours 39 minutes, and no serious adverse events occurred. Complications of the procedures included a small blister, muscle ablation, and acute biochemical pancreatitis that was asymptomatic and self-resolving. Focused ultrasound seems promising for achieving local control of tumor growth with an average of 63% of the tumors ablated after one or two treatments. The procedure was associated with few adverse events compared to surgery or radiation, and it can be repeated without toxicity to normal tissue.

    Bone Pain

    Osteoid Osteoma: Magnetic Resonance Guided High Intensity Focused Ultrasound for Entirely Non-Invasive Treatment. A Prospective Developmental Study.

    Alessandro Napoli, M.D., Sapienza University of Rome, presented results of a study treating 15 patients with osteoid osteoma, a rare benign tumor causing localized bone pain that affects young adults. The patients were treated with MR-guided focused ultrasound and followed up at 1, 6, and 12 months post-treatment. There were no treatment-related complications. A statistically significant difference was noted between the overall pre- and post-treatment visual analogue scores for pain (8.3 and .6 respectively).


    ABOUT FOCUSED ULTRASOUND
    Focused ultrasound is a revolutionary, early-stage therapeutic technology with the potential to transform the treatment of many serious medical disorders. This breakthrough technology uses ultrasonic energy guided by magnetic resonance or ultrasound imaging to treat tissue deep in the body without incisions or radiation. Multiple intersecting beams of ultrasound are directed and concentrated on a target as small as a grain of rice, much like a magnifying glass can focus multiple beams of light on a single point.
    Focused ultrasound is currently approved in the U.S. to treat uterine fibroids and painful bone metastases, and there are a growing number of clinical applications in various stages of research and development around the world, including Parkinson’s disease, essential tremor, neuropathic pain, breast and prostate cancer, and brain tumors.

    ABOUT THE INTERNATIONAL SOCIETY FOR THERAPEUTIC ULTRASOUND
    The International Society for Therapeutic Ultrasound (ISTU) is a non-profit organization founded in 2001 to increase and diffuse knowledge of therapeutic ultrasound to the scientific and medical communities, and to facilitate the translation of therapeutic ultrasound techniques into the clinical arena for the benefit of patients worldwide.

    ABOUT THE FOCUSED ULTRASOUND FOUNDATION
    The Focused Ultrasound Foundation was created to improve the lives of millions of people worldwide by accelerating the development and adoption of focused ultrasound therapies. The Foundation works to clear the path to global adoption by coordinating and funding research, fostering collaboration among stakeholders, and building awareness of the technology among patients and professionals. The Foundation is dedicated to ensuring that focused ultrasound finds its place as a mainstream therapy for a range of conditions within years, not decades. Since its establishment in 2006, the Foundation has become the largest non-governmental source of funding for focused ultrasound research. More information about the Charlottesville, Virginia-based Foundation can be found at www.fusfoundation.org.

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  • Focused Ultrasound Clinical Trial for Breast Fibroadenoma Gains FDA Approval

    Theraclion, a manufacturer of focused ultrasound equipment based in France, announced today that they have attained approval from the US Food and Drug Administration (FDA) for a feasibility study in the United States. Their device, EchoPulse, uses ultrasound-imaging to guide the treatment of breast fibroadenoma using focused ultrasound. Breast fibroadenoma are benign tumors of the breast, and it is estimated that 10% of women will experience them in their lifetime.  

    Theraclion will collaborate with the University of Virginia on this study, evaluating 20 patients to prove safety and efficacy of the treatment. This trial is considered first phase, and a multicenter pivotal study is planned upon the trial’s completion.

    Read the release. 

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  • Foundation Publishes Global Report on Focused Ultrasound – A Resource for all Stakeholders

    The Focused Ultrasound Foundation has published its January 2014 Focused Ultrasound Global Perspective report, a comprehensive overview of the state of the technology, including facts and figures on approved indications, manufacturers, research centers, and treatment sites. This report will serve as a trusted resource for academia, government, industry, and investors, enabling them to monitor progress in the field and guide decision making.

    The report is now available on our website. An update will be produced every six months, identifying significant research and commercialization trends for the technology.

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  • Focused Ultrasound Makes Cover of DOTmed HealthCare Business News

    Focused ultrasound secured a spot on the front page of the January 2014 issue of DOTmed HeathCare Business News.  The article, which asks “is focused ultrasound medicine’s best kept secret,” chronicles the conception of the technology and details the current state of development and adoption for some important conditions, including uterine fibroids, Essential Tremor, Parkinson’s disease, Obsessive Compulsive Disorder, and prostate cancer. It also covers next steps for the technology, including the arena of widespread reimbursement.

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  • Company Profile: Kona Medical

    Kona Medical, Inc. is pioneering the use of focused ultrasound (FUS) to noninvasively treat hypertension through ablation of the renal nerves. Renal nerves are located near the renal arteries supplying blood to the kidneys and can play a significant role in regulating blood pressure. Recent clinical data have shown that ablation of renal nerves can result in profound and lasting reduction in hypertension in patients whose blood pressure is not adequately controlled by medication.

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  • InSightec Names New President, CCO

    InSightec Ltd, a leader in MRI guided Focused Ultrasound therapy, has announced that Robert Sigal, MD, PhD, has taken over the role of President and Chief Commercial Officer. He will be responsible for all the commercial aspects of InSightec, reporting to Dr. Kobi Vortman, CEO and Founder of InSightec Ltd.

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  • Two Focused Ultrasound Companies Recognized for Innovation

    As a true testament to the potential of focused ultrasound to change medicine, TWO out of 15 companies selected by Fierce Medical for their top 15 innovators of the year are focused ultrasound companies: InSightec and Kona Medical.

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  • ISTU Meeting Gave Added Emphasis to Clinical Studies

    Held in Shanghai, China from May 12-15, the 2013 meeting of the International Society of Therapeutic Ultrasound (ISTU) drew about 200 attendees and devoted an entire day to clinical presentations, indicating the society’s increasing emphasis on patient applications of therapeutic ultrasound.

    Feng Wu, MD, PhD received the 2013 Fry Award, which is given annually to an individual who has made outstanding contributions to therapeutic ultrasound. Wu is a HIFU Consultant and Senior Clinical Scientist at Oxford University in the United Kingdom.

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  • American Urologists Show Strong Interest in HIFU

    From the level of traffic at its booth to the “Best Poster” honors bestowed on two abstracts featuring its HIFU treatment for prostate cancer, focused ultrasound device maker EDAP TMS reported a “heightened level of interest and enthusiasm” among physicians and others attending the 2013 meeting of the American Urological Association (AUA) in May. Now in use in 29 countries, EDAP’s prostate cancer treatment device – the Ablatherm – is awaiting regulatory approval in the U.S.

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  • Canadian Study Assessing Thermal Ultrasound Treatment for Prostate Cancer

    Patients with localized prostate cancer are receiving treatment in a new clinical study assessing the safety of a transurethral ultrasound ablation system developed by Toronto-based Profound Medical Inc. The system, which uses a specially designed wand to deliver thermal ablative therapy, operates under MR guidance. It works on a variety of MRI platforms, can be moved from scanner to scanner and treats the whole prostate gland in one session.

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  • Seattle Center To Be a Major Force in Focused Ultrasound Brain Studies

    First patient trial at Swedish Medical Center will be for essential tremor

    One of the most prestigious neuroscience centers in the world is gearing up to become a major clinical force in MR-guided focused ultrasound brain research. Swedish Neuroscience Institute (SNI) at the Cherry Hill campus of Swedish Medical Center in Seattle, Washington, USA will soon treat patients with essential tremor as part of  an upcoming Phase III multicenter randomized trial and is considering studies for epilepsy, Parkinsonian tremor, metastatic tumors and intracerebral hemorrhage.

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  • Industry Trade Reports on Positive Essential Tremor Data Using Focused Ultrasound

    The Gray Sheet, a cornerstone medical device publication for the healthcare industry, touts promising data on FUS for essential tremor and recognizes the Foundation's unique model in supporting research.

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  • SonaCare’s Devices Treat Prostate Cancer, Other Urological Conditions

    In a March 14 press release, SonaCare announced that it would showcase a retooled version of the Sonablate 500 system  and display the Sonatherm for the first time ever during this month’s European Association of Urology Congress in Milan. The company also reported a 130% increase in global sales during 2012 and said that yearly sales had more than doubled since 2011. SonaCare Medical, LLC – the new name of focused ultrasound device-maker U.S. HIFU – is gearing up for growth. According to Chief Development Officer Mark Carol, MD, the company plans to add the world’s largest healthcare market – the U.S. – to the list of countries where its flagship Sonablate system is cleared to treat prostate cancer. The company is also gearing up to commercialize its Sonatherm system, a laparoscopic HIFU surgical ablation device that received 510(K) clearance from the U.S. Food and Drug Administration (FDA) in 2008 to treat organs other than the prostate.

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  • EDAP Leads the Charge in Commercializing FUS for Prostate Cancer

    The year 2013 has gotten off to a solid start for device maker EDAP TMS with a steady stream of positive business and research news. The company has introduced its new Focal.One device for prostate cancer and is progressing in its quest for U.S. regulatory approval of its Ablatherm-HIFUsystem for localized prostate cancer.

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  • EDAP Submits U.S. FDA Pre-Market Approval Application for Ablatherm(R)-HIFU for Treatment of Low Risk, Localized Prostate Cancer

    LYON, France, Feb 01, 2013 (GLOBE NEWSWIRE via COMTEX) -- EDAP TMS SA EDAP, the global leader in therapeutic ultrasound, announced today the submission of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) on January 31, 2013 for the Company's Ablatherm-HIFU (High Intensity Focused Ultrasound) for treatment of low risk, localized prostate cancer. EDAP's PMA submission includes data from the ENLIGHT study, a multi-center U.S. Phase II/III clinical trial that completed the two year follow-up needed to evaluate its primary endpoint in August 2012, as well as data from the Company's extensive worldwide database of treatment information and follow-up data from patients who have undergone HIFU therapy for prostate cancer.

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  • Clinical Trial is Evaluating Theraclion’s Ultrasound-Guided Device in Treating Bone Tumor Pain

    The Focused Ultrasound Surgery Foundation has awarded a $232,808 research award to Wladyslaw M. Gedroyc, M.D. of St. Mary’s Hospital in London for a two-year randomized clinical trial comparing MR-guided focused ultrasound with radiofrequency ablation in the treatment of back pain caused by facet joint disease.

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  • Theraclion's EchoPulse receives CE marking for treatment of breast fibroadenoma

    Theraclion receives CE marking approval for its ultrasonic device EchoPulse, in the non-invasive treatment of breast fibroadenomas;

    Fibroadenoma is the most widely spread breast benign tumor; 

    EchoPulse has already been validated in European clinical trials.

    "The CE marking widens the use of our technology in the major area of breast fibroadenoma. Our technology can now be offered to all women suffering from this pathology in Europe. They can benefit from a non-invasive outpatient treatment without general anesthesia which puts an end to the embarrassment and anxiety triggered by this kind of tumor.Non-invasive focused ultrasound surgery guided by real-time ultrasound imaging is consistent with the logic of developing lesser invasive treatments and a reduction of health costs. This market authorization in Europe will allow us to grow by creating non-invasive surgery centers based on our resulting echotherapy solution within leading hospitals and clinics. Other tumors beside breast fibroadenomas will be treated in a non-invasive manner in the near future,” says Jean-Yves Burel, CEO of Theraclion.

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  • InSightec’s ExAblate Neuro System Awarded European CE Mark for Non-invasive Treatment of Neurological Disorders in the Brain

    ExAblate treatment indicated for use for essential tremor, tremor dominant Parkinson’s disease and neuropathic pain

    Tirat Carmel (December 4, 2012).  InSightec Ltd. announced that its transcranial focused ultrasound system, ExAblate Neuro, has been awarded the European CE mark for the treatment of neurological disorders in the brain including essential tremor, Parkinson’s disease and neuropathic pain.

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  • Vendor Profile: Alpinion Medical Systems Offers a Pre-clinical Focused Ultrasound System

    Based in Seoul, Korea, Alpinion Medical Systems has been offering ultrasound devices since 2007. Half of its 185 employees are R&D engineers, indicating the company’s strong focus on product development and innovation.

    Alpinion has three core technologies: diagnostic ultrasound; ultrasound transducer technology and therapeutic ultrasound. It entered the therapeutic ultrasound market in 2011 with the introduction of its first high intensity focused ultrasound product, the VIFU 2000. A year earlier, the company opened an office in Seattle, Washington to focus on R&D for the VIFU 2000 and to expand sales in North America. Alpinion also has sales offices in Germany and China.

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  • EDAP Concludes Follow-up Phase of its U.S. Prostate Cancer Study

    French focused ultrasound device maker, EDAP TMS SA, reports that the two-year follow-up phase has concluded for its multi-center U.S. Phase II/III clinical trial for the indication of low risk, localized prostate cancer. Data analysis is now underway, and the company is preparing a comprehensive Premarket Approval (PMA) submission, which is the next step in the FDA approval process.

    Read press release

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  • New Report Provides Excellent Overview of Focused Ultrasound Foundation's History, Mission and Unique Approach to Venture Philanthropy

    “Ultrasound foundation speeds medical advances” is title of  an interview with Dr. Neal Kassell in today’s issue of C-ville Weekly. The article provides an excellent overview of the Focused Ultrasound Foundation’s history, mission and unique approach to venture philanthropy.  READ ARTICLE

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  • Philips and Celsion Receive FDA Go-ahead for Phase II Study of ThermoDox and MR-Guided HIFU in Bone Cancer

    ANDOVER, MA and LAWRENCEVILLE, NJ -- (Marketwire) -- 08/07/12 -- Royal Philips Electronics (NYSE: PHG) (AEX: PHI) and Celsion Corporation (NASDAQ: CLSN) today announced that the U.S. Food and Drug Administration (FDA) has provided clearance to initiate a clinical study supporting a joint development program for Celsion's ThermoDox® combined with Philips' Sonalleve MR-HIFU (MR-guided high intensity focused ultrasound) technology for the palliation of painful metastases to the bone caused by lung, prostate or breast cancers. The companies expect to initiate a Phase 2 study in this indication in the second half of 2012.

    READ FULL PRESS RELEASE

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  • PanAm HIFU Opens Prostate Cancer Treatment Center in Mexico

    Sarasota, Florida-based PanAm HIFU has opened a prostate cancer treatment site at Amerimed Hospital in Cancun, Mexico. The new site represents a partnership between PanAm and EDAP TMS SA, manufacturer of the Ablatherm-HIFU system, which is approved in Europe and generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment.

    The Cancun center is PanAm’s second offshore site; the first is in London, England. Medical Director Ronald E. Wheeler, MD, explained that PanAm’s new facility will satisfy increasing patient demand and serve as a HIFU technology training site for American physicians “in preparation for [Ablatherm’s] U.S. approval.” READ PRESS RELEASE

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  • UVA Focused Ultrasound Center Receives an Additional $1.5M in State Funding

    The Focused Ultrasound Foundation’s first designated Center of Excellence at the University of Virginia will be receiving an added $1.5 million for research over two years from the Commonwealth of Virginia. As a participant in the public-private partnership that created the UVA Center in 2009, the Commonwealth had previously provided $4 million in support.

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  • EDAP Realigns Executive Team to Focus on US Opportunities

    EDAP TMS SA of Lyon, France has relocated its Chief Executive Officer Marc Oczachowski to the US. "The U.S. market is critically important for EDAP," said Philippe Chauveau, Chairman of the company’s Board of Directors. "We see significant growth drivers in the US, both in the lithotripsy market and in continuing to drive our Ablatherm-HIFU program toward FDA submission, targeted for fourth quarter 2012."  

    The realignment impacted the accountabilities of the company’s Chief Financial Officer Eric Soyer and Japanese subsidiary CEO, Jean Francois Bachelard. NEWS RELEASE

    Continue reading >

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