October 28, 2021 - HistoSonics Device Earns FDA Breakthrough Designation - and more news

The program allow fast-tracking of certain novel devices...                   October 28, 2021 IN THIS ISSUE Top News | Foundation News | Patient News | Research News Industry News | Webinars | Events     HistoSonics Focused Ultrasound Platform Receives FDA Breakthrough Device Designation The US Food and Drug Administration (FDA) established the Breakthrough Devices Program in 2018 to allow fast-tracking of certain novel devices. The HistoSonics platform, called EdisonTM, uses histotripsy to noninvasively and mechanically destroy tissue. The procedure is being investigated in patients with liver tumors in clinical trials in Europe and the US.  READ MORE >  LEARN MORE ABOUT THE LIVER TUMOR TRIALS > Research News Clinical Trial Update: Histotripsy for Liver Tumors Two ongoing clinical trials are investigating noninvasive histotripsy to mechanically destroy liver tumors. The trials – both called #HOPE4LIVER – are seeking patients at eight sites in the US and five in Europe.   The platform used in both trials was recently granted Breakthrough Device Designation by the FDA.   LEARN MORE ABOUT THE US TRIAL > LEARN MORE ABOUT THE EUROPEAN TRIAL > Pancreatic Cancer Clinical Trial Begins in Korea Clinicians at Seoul National University Hospital are using focused ultrasound on pancreatic cancer lesions to enhance the effectiveness of chemotherapy drugs. To date, 11 of 30 patients have been treated in this Foundation-funded trial. READ MORE >  Case Report: Focused Ultrasound for Facetogenic Low Back Pain A 78-year-old male suffered from low back pain for more than six years before focused ultrasound therapy provided relief. The Foundation thanks Christin Tiegs-Heiden, MD, radiologist at Mayo Clinic, for providing this case report. READ MORE >  Elisa Konofagou, PhD, Elected to the National Academy of Medicine Dr. Konofagou is among the inductees of the National Academy of Medicine, one of the highest honors in the fields of health and medicine. She is a Professor of Biomedical Engineering and Radiology at Columbia University. READ MORE >  NIH BRAIN Initiative Awards Multi-Year Grant for Focused Ultrasound Neuromodulation Research Bin He, PhD, of Carnegie Mellon University, has received a multimillion-dollar grant from the National Institutes of Health (NIH) BRAIN Initiative. The funding will support the investigation of the cellular and neural circuit neuroscience mechanisms for transcranial focused ultrasound neuromodulation. READ MORE >  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. READ MORE >  Employment Opportunities Available in the Focused Ultrasound Community The Foundation curates a hub of available positions within the international focused ultrasound community. See more than 20 positions on our job board. Please submit any relevant opportunities at your organization. VIEW & SUBMIT OPEN POSITIONS >  Visit our free, online research library of focused ultrasound publications.   More Research News Media coverage of the recent publication of clinical trial data using focused ultrasound to aid drug delivery to metastatic breast cancer from U.S. News & World Report, WebMD, The Globe and Mail, The Guardian, and The Scientist Children’s National Hospital Launches $500 Million Campaign to Transform Pediatric Health | Children's National Hospital Treatment Efficacy for Uterine Fibroids | Contemporary OB/GYN Behind the Research: A Medical Oncologist on Tough-to-Reach Tumours and Promising Research | Sunnybrook Health Officials to Celebrate Fralin Biomedical Research Institute at VTC Addition Grand Opening | Virginia Tech Fralin Biomedical Research Institute at VTC Takes Delivery of New Scanner for MR–Guided Focused Ultrasound Facility | Virginia Tech Foundation News Watch Now: Advances in Breast Cancer Treatment Webinar The Foundation convened four experts who are leading efforts to improve the treatment of patients with breast cancer. Learn about the latest advances in focused ultrasound–based therapies. October is Breast Cancer Awareness month.   WATCH THE RECORDING >  Workshop Series: Bubble Activity in Therapeutic Ultrasound Details are now available for the final workshop in the “Detecting, Mapping, and Quantifying Bubble Activity in Therapeutic Ultrasound” virtual series. Registrants can watch previous workshop recordings in the online portal. Join us for a final discussion session Friday, October 29, at 10:00 am Eastern. LEARN MORE AND REGISTER >  In Memoriam: Robert Grossman, MD We are saddened to report the death of Robert Grossman, MD, a pioneering neurosurgeon and chair of the Foundation’s Data Safety Monitoring Board. Dr. Grossman assisted in developing the framework for the Foundation’s Brain Program, a central initiative for the organization. READ MORE >  Patient News Essential Tremor Patient and Cancer Survivor Finds Relief with Focused Ultrasound Karen’s tremors started in her 30s but worsened when she underwent chemotherapy for breast cancer. When medication stopped working, she chose focused ultrasound and was treated at the University of Utah.   She now says that focused ultrasound was “a miracle.”   READ HER STORY > More Patient News His Hand Shook Uncontrollably Until UVA’s Focused Ultrasound Stopped the Tremor (video) | UVAToday Parkinson's Treatment Holds Hope for St. Pete Sculptor | Bay News 9 Tampa Prostate Cancer: Symptoms, Diagnosis, Treatment | Rising Kashmir Scots Man Signs Own Name for First Time in 20 Years after Groundbreaking Treatment to Banish Violent Shaking | Daily Record UK Medical Moment: Prostate Cancer | NBC16 South Bend, IN High Intensity Focused Ultrasound is a Minimally Invasive Treatment for Prostate Cancer | ABC15 Arizona Industry News Watch Now: Webinar on Team Building De-Mystified The Foundation’s FUS Partners program recently hosted a webinar of strategies and tactics for finding and keeping great people.   Drue De Angeles and Mike Travis, veterans in the executive search business, shared their experience and advice. WATCH THE RECORDING >  Foundation Issues Comments on Proposed Repeal of the MCIT Program The Medicare Coverage of Innovative Technology (MCIT) program is designed to help expedite reimbursement coverage for FDA-approved breakthrough devices.   The Centers for Medicare and Medicaid Services (CMS) has proposed a rule to repeal the program. The Foundation and our partners have formally expressed disappointment in this decision. READ THE COMMENTS >  Webinars Detecting, Mapping, and Quantifying Bubble Activity in Therapeutic Ultrasound The final session is Friday, October 29, at 10:00 am Eastern. Hosted by the Focused Ultrasound Foundation and the American Institute of Ultrasound in Medicine's Future Fund LEARN MORE AND REGISTER > Focused Ultrasound for the Pediatric and Young Adult Population Thursday, November 18, at 1:00 pm Eastern. Presented by Lauren Powlovich, MD, the Foundation’s Associate Chief Medical Officer Hosted by the Focused Ultrasound Foundation and the American Institute of Ultrasound in Medicine LEARN MORE AND REGISTER > Recent Webinar Recordings Novel Advances in Breast Cancer Treatment | Hosted by the Focused Ultrasound Foundation (1 hour) Team Building De-Mystified: Strategies and Tactics for Finding and Keeping Great People | Hosted by the Focused Ultrasound Foundation’s FUS Partners Program (1 hour 2 minutes) Do you have news for our newsletter? Tell us about it!   Upcoming Events November 4-6, 2021 Veterinary Cancer Society Annual Conference | VIRTUAL MEETING November 4-7, 2021 DIPG/DMG Collaborative: DIPG Research Symposium, Houston, TX November 8-11, 2021 Neuroscience 2021 | VIRTUAL MEETING November 10-14, 2021 Society for ImmunoTherapy of Cancer (SITC) 36th Annual Meeting, Washington, DC and VIRTUAL MEETING November 18-21, 2021 26th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), Boston, MA  November 28 – December 2, 2021 Radiological Society of North America (RSNA) 107th Scientific Assembly and Annual Meeting, Chicago, IL November 29 – December 3, 2021 Acoustical Society of America (ASA) 181st Meeting, Seattle, WA