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 surgical robot.

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.

FDA Commissioner Dr Marty Makary. 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 ...

The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity in some patients, citing a recent study and new data.

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