FDA Related News

Feds Sued Over Removing Web Site Health Info

Represented by Public Citizen Litigation Group, Doctors for America sues FDA and several other agencies over their removal of Web pages and datasets n...

Medical Devices

Lumitron Get Breakthrough Status for New X-Ray

FDA grants Lumitron Technologies a breakthrough device designation for its HyperVIEW X-Ray system for contrast-enhanced imaging for diagnosing breast ...

Human Drugs

RFK Jr.'s HHS Nomination Moves to Senate Floor

HHS secretary-nominee Robert F. Kennedy Jr.s nomination moves one step closer to completion after the Senate Finance Committee voted to advance it to ...

Medical Devices

Medtronic Recalls Cerebrospinal Fluid Drain Device

Medtronic Neurosurgery recalls certain Becker and Exacta External Drainage and Monitoring Systems due to a risk for cracks and leaks in device stopcoc...

Federal Register

2 Guides on Cell/Tissue Disease Transmission Delayed

Federal Register notice: FDA delays by three months the effective dates of two final guidances on reducing the risk of transmission of sepsis-associat...

Human Drugs

Olympus Recalls Endoscope Accessory

Olympus recalls its MAJ-891 endoscope accessory due to infection risks that may result from improper device reprocessing.

Human Drugs

Lawyers Critique Guide on Unapproved Use Dissemination

A Duane Morris client alert analyzes a recent FDA guidance on communicating scientific information to healthcare professionals about medical product u...

Human Drugs

Pfizer Seeks Braftovi Full Approval in Colon Cancer

Pfizer seeks full approval for current accelerated-approved Braftovi (encorafenib) in combination with cetuximab (Erbitux) and mFOLFOX6 (fluorouracil,...

Medical Devices

FDA Clears Hearing Aid/Smart Glasses

FDA clears an EssilorLuxottica 510(k) for its over-the-counter Nuance Audio Glasses that provide an open-ear hearing solution integrated into a pair o...

Medical Devices

Gyder Hip System Cleared by FDA

FDA clears a Gyder Surgical 510(k) for the Gyder Hip System and its use in positioning the acetabular cup during hip replacement surgeries.