The U.S. Food and Drug Administration has issued a warning letter to Medline Inc. MDLN, following an inspection that ...

FDA denies exemption request for radiology AI devices, requiring continued 510(k) premarket review to ensure safety and effectiveness.

Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...

Regulatory Focus is the only source of timely, quality news and information fully dedicated to daily online coverage of the global regulation of healthcare products. An experienced team of reporters ...

Add Yahoo as a preferred source to see more of our stories on Google. FDA commissioner Marty Makary made the announcement during the 2026 CES trade show The US Food and Drug Administration (FDA) is ...

This morning the US Food and Drug Administration offered up a set of draft guidelines for how it might regulate certain mobile medical apps. While this set of guidelines was years in the making, it ...

How do companies move away from making costly errors during FDA inspections? That’s the question Michael Drues, president at Vascular Sciences and an independent regulatory and quality consultant, ...

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...

CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the ...