The DCB currently remains an investigational device and is not available for sale in the US. "Airiver Medical receives FDA ...

The Association for the Advancement of Medical Instrumentation (AAMI) officially welcomes speakers from the U.S. Food and Drug Administration (FDA) to its upcoming medical device standards conference, ...

Airiver Medical, a clinical stage company developing technologies to help patients who suffer from certain respiratory tract conditions, was granted designation as a Breakthrough Device from the U.S.

Medical device lobbyists called for more staffing transparency in user fee negotiations with the Food and Drug Administration ...

Explore how FDA's risk-averse approach to clinical decision support software regulation reveals challenges in balancing innovation and patient care.

On February 24, 2026, the U.S. Food and Drug Administration announced the establishment of new Produce Regulatory Program Standards (PRPS), developed in collaboration with the Nat ...

Consider the case of patient WB, a 79-year-old male with recurrent diffuse large B cell lymphoma. He was referred for ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — The layoffs over the ...

The FDA will drop its longtime two-study standard for the drug approval process - making it a one study rule. Dozens of Democrats to boycott Trump's State of the Union address Why no one is winning ...

Update: The FDA reversed its decision on Feb. 18 and agreed to consider Moderna's application. Read the latest here. Our earlier story is below. The Food and Drug Administration is refusing to ...

The Food and Drug Administration has reversed course and agreed to review Moderna’s application for the first mRNA-based flu vaccine under a revised approach, company and federal officials said ...