Moon Surgical, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two major advancements ...

Moon Surgical today announced it received FDA 510(k) clearance for two new features on the Maestro robotic surgical assistant ...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to PathAI for its digital pathology image management ...

The FDA decision also included a Predetermined Change Control Plan (PCCP), enabling PathAI to validate and implement specified major changes such as additional displays, scanners, file formats and ...

BOSTON, June 30, 2025 (GLOBE NEWSWIRE) -- PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that it has received 510(k) clearance from the U.S.

In a surprise post this afternoon, new FDA Commissioner Dr Martin Makary announced a completed pilot at the FDA of a generative AI-based system for speeding up drug review - and plans to roll out ...

The FDA is moving at breakneck speed to roll out a generative artificial intelligence (AI) tool for speeding up regulatory reviews, announcing its launch nearly a month ahead of the 30th June ...

FDA has a set timeline to review drugs; a norm is 10 months, called a PDUFA date. Priority Review can shorten this to six months for critical treatments. PDUFA dates are impactful, influencing ...