Twelve Members of the Independence Through Enhancement of Medicare and Medicaid (ITEM) Coalition Sign Letter to CMS Seeking Clarification of Prior Decision Making and Action to Bring Novel Hearing ...

On August 7, 2024, the Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET) (Final Notice). The long-anticipated Final ...

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ST. LOUIS, Jan. 13, 2026 /PRNewswire/ -- Amplifi Vascular, Inc., has been granted Breakthrough Device Designation and Category B assignment from the Centers for Medicare & Medicaid Services (CMS) for ...

The Background: The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") ...

The Transitional Coverage for Emerging Technologies Pathway will expedite the coverage of certain FDA-designated breakthrough devices, according to an Aug. 8 news release from the agency. Each year, ...

Medicare will speed nationwide payment decisions for as many as five promising new medical devices a year, a move that could get some products to patients earlier and spare companies from a ...

CMS is considering adding new medical device cybersecurity requirements for hospitals participating in Medicare after receiving recommendations from the HHS Office of Inspector General, according to a ...

A group of stakeholders including medical device makers have penned a letter to Centers for Medicare & Medicaid Services administrator Mehmet Oz to urge the agency to cover breakthrough medical ...