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CMS Launches New TCET Program to Expedite Reimbursement for Breakthrough Devices

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Key Points A new program for the Centers for Medicare and Medicaid Services (CMS) may expedite Medicare reimbursement national coverage determinations for devices with breakthrough device designation. October 31 is the first quarterly deadline to apply to the Transitional Coverage for Emerging Technologies (TCET) program. The Centers for Medicare and Medicaid Services (CMS) has established a new program called the Transitional Coverage for Emerging Technologies (TCET) that can help expedite Medicare reimbursement for some medical devices with breakthrough device designation. Up to five devices will participate in the program each year. The goal of the TCET program is to enable a more efficient and transparent Medicare coverage review process with enhanced communications between CMS and industry before the device earns US Food and Drug Administration (FDA) authorization. Clear evidence requirements and defined timelines for final coverage actions will also be available. CMS has stated that the goal is to secure a national coverage determination for TCET products within six months after FDA authorization, which is three to six months faster than the regular process. For TCET products needing additional data to support a CMS coverage determination, a coverage with evidence development path may allow additional studies with transitional CMS coverage for five or more years while the evidence is gathered.   At least six focused ultrasound devices have earned Breakthrough Device designation: Carthera for its SonoCloud-9 device for glioblastoma, Cordance Medical for its NeuroAccess liquid biopsy device, EDAP TMS for its Focal One high-intensity focused ultrasound (HIFU) platform for treating deep infiltrating rectal endometriosis, HistoSonics for its EdisonTM histotripsy platform, Acoustiic  for its ultrasound arrays, and SONIRE Therapeutics Inc’s HIFU therapy system for the treatment of pancreatic cancer. “Collective advocacy of our focused ultrasound and medical device community and our various partners have made a positive influence in the adoption of new programs like the TCET program,” said Jessica Foley, PhD, the Foundation’s Chief Scientific Officer and Managing Director for Government Affairs. “It is a good start and we encourage CMS to consider making this pathway available more broadly than its current limit of five devices per year.”  Apply for the TCET ProgramNomination applications are accepted quarterly, and the next deadline is October 31. Device manufacturers are encouraged (but not required) to submit a voluntary, non-binding letter of intent 18 to 24 months before FDA authorization.   Learn MoreFor more information about the program, see the CMS notice, watch the CMS webinar, or contact FUS Partners if you need connections to third-party reimbursement experts who can assist you on a fee-for-service basis. 
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Company Profile: PRO HITU

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Shenzhen PRO HITU Medical Co., LTD., is a Chinese research and development company that builds ultrasound-guided focused ultrasound systems to treat uterine fibroids, placenta implantation, chronic pelvic pain, and more.
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Company Profile: Theraclion

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Theraclion’s SONOVEIN device has the CE Mark for the treatment of varicose veins, and they are exploring breast cancer treatment and a strategic global expansion. 
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Arrayus Focused Ultrasound Device Approved in Canada to Treat Uterine Fibroids

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Key Points Based on data from its first clinical trial, Arrayus has gained Health Canada approval to treat uterine fibroids.  The device has a fully phased array and includes intuitive treatment planning tools and real-time therapy monitoring.  Arrayus Technologies, Inc. has announced that its MRI-guided focused ultrasound device obtained Health Canada approval for the ablation of uterine fibroid tissue. The ruling was based on data from the company’s first-in-human clinical trial.  Uterine fibroids are benign tumors that can greatly affect quality of life for women, mainly in their reproductive years. Symptoms include heavy bleeding, problems urinating, and pain. Up to 80% of women will be diagnosed with uterine fibroids in their lifetime.  According to their press release, the Arrayus device is the world’s first clinically available fully phased array that includes intuitive treatment planning tools and real-time therapy monitoring.   “Securing Health Canada approval marks a pivotal moment in the evolution of our technology, but it’s only the beginning,” said James O’Reilly, CEO of Arrayus. “Our platform has the potential to transform patient care across multiple medical specialties. We are committed to pushing the boundaries of medical innovation to reduce the burden on the healthcare system and improve patient outcomes worldwide.”  The Canadian company is also developing focused ultrasound for oncological applications and is seeking its first institutional round of funding to support those endeavors.    Arrayus was founded by renowned focused ultrasound researcher Kullervo Hynynen, PhD, based on work completed during his time at Brigham and Women’s Hospital and Sunnybrook Health Sciences Center. Arrayus was formerly known as Harmonic Medical.  Read the Press Release  Read our Company Profile from September 2022 
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