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 ...
Amplifi Vascular, Inc., has been granted Breakthrough Device Designation and Category B assignment from the Centers for Medicare & Medicaid Services (CMS) for the Amplifi Vein Dilation System. This ...
The Centers for Medicare and Medicaid Services shared a final notice on Wednesday for a new pathway to cover breakthrough medical devices. The pathway, called Transitional Coverage for Emerging ...
The Centers for Medicare and Medicaid Services (CMS) announced October 28 that it will cover renal denervation procedures for patients with uncontrolled hypertension. The decision covers two devices ...
On June 27, 2024, the Ensuring Access to Breakthrough Products Act of 2024 (H.R. 1691) was marked up and reported out of the House Ways and Means Committee. This action brings Medicare beneficiaries ...
Medical technology lobby AdvaMed is fed up with the Centers for Medicare and Medicaid Services. In a letter sent to the agency on Thursday and shared with STAT, the group urged CMS to act on ...
CMS nominee Weems has been a leader in the adoption of health IT. Despite the fact that Kerry Weems, President Bush's nominee to head CMS, has two decades of experience at HHS, little is known about ...
The Food and Drug Administration and CMS are advocating for the use of unique identification numbers in billing records for medical devices, The Wall Street Journal reports. In a letter this week to ...
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 ...
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