Fierce Healthcare

CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices

The Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced on Thursday ...
STAT

Beyond detection: In the age of clinical AI, what counts as an FDA ‘breakthrough’ medical device?

Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy — with an emphasis on the impacts of digital health care for patients, providers, and businesses. You can ...
Morningstar

Airiver Medical Granted FDA's Breakthrough Device Designation for Pulmonary Drug Coated Balloon to Treat Central Airway Stenosis; First Patient Treated in Clinical Trial

BROOKLYN PARK, Minn., March 4, 2026 /PRNewswire/ -- Airiver Medical, a clinical stage company developing technologies to help patients who suffer from certain respiratory tract conditions, was granted ...