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 ...
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

Congress must pass legislation to ensure Medicare covers breakthrough medical technologies

Makower is the Yock family professor of medicine and bioengineering at the Stanford Schools of Medicine and Engineering, and the Byers family director and co-founder of the Stanford Mussallem Center ...
Regulatory Affairs Professionals Society

FDA, CMS propose new parallel review pathway for breakthrough devices

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...
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 ...
MedPage Today

FDA, CMS to Launch Speedy Coverage Pathway for Breakthrough Medical Devices

Certain breakthrough-designated medical devices that receive market authorization will become eligible for Medicare coverage ...