The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

(RTTNews) - GE HealthCare Technologies Inc. (GEHC) Wednesday said that it has received FDA 510(k) clearance for its innovative SIGNA MAGNUS 3.0T high-performance, head-only magnetic resonance imaging ...

The FDA has begun traceback efforts, suggesting that investigators have identified some possible pathogen sources. However, the FDA has not reported what food it is tracing and has not begun on ...

The FDA reorganization — a cornerstone of Jim’s efforts — became official on Oct. 1. At an upcoming Alliance webinar, Jones will provide an overview of the changes, focusing on how much has ...

Last week, the outgoing leader of the FDA’s devices center ... This week, the agency made it official. The Center for Devices and Radiological Health (CDRH) confirmed the appointment Tuesday.

After Andrew Soukup of Covington & Burling and Jay Lefkowitz of Kirkland & Ellis argued the motion to dismiss for the ...

Nordic Bioscience, a leading biomarker company, announced that its CPa9-HNE biomarker assay received a Letter of Support (LoS ...

One FDA official said they believe the original studies using the drug were “methodologically unsound and do not match today’s standard.” The drug is supposed to relieve congestion by ...

27 and Oct. 11. Taylor Farms notified its customers directly about the onion recall but did not tell the public about it, an FDA official said. Companies often issue press releases and the FDA ...

Marco Rubio wrote to the Food and Drug Administration (FDA) and Department of Homeland Security (DHS) Wednesday, slamming the ...

As AI technology evolves rapidly, the FDA is tackling the challenge of balancing innovation with patient safety, shaping regulations that ensure AI tools remain effective throughout their entire ...

“This is the first approved indication for Orlynvah and the first FDA-approved product for Iterum,” the company stated. “We are so pleased to have achieved this historic milestone and would ...