dermatologyadvisor7h
FDA Alert: Pulmonology Drug Approvals, Recalls, and Device Updates
FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.
FDA Approves Blood Test for Alzheimer's Disease
The FDA has granted medical manufacturer Beckman Coulter a Breakthrough Device Designation for its new plasma ratio, a blood ...
Stockhead on MSN1d
Health Check: Alterity angles for fast-track FDA approval after positive trial results tackling Parkinson’s-like disorder
Alterity plans to seek US FDA fast-track approval after posting positive phase II results for multiple system atrophy ...
Health Affairs4h
We Need More Robust Post-Market Surveillance For Health Care AI
The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.
Los Angeles Business Journal4d
Avita Gets FDA Nod For Device
Valencia-based Avita Medical Inc. has received FDA approval for a version of its second-generation Recell skin cell ...
JD Supra2h
Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the ...
JenaValve Trilogy System’s FDA approval to expand indications to aortic regurgitation
The US Food and Drugs Administration (FDA) is expected to approve the JenaValve Trilogy System, a transcatheter aortic valve ...
Hosted on MSN2d
Merit Medical Celebrates FDA Approval of WRAPSODY™
An update from Merit Medical Systems ( ($MMSI) ) is now available. On January 28, 2025, Merit Medical Systems held a conference call to discuss ...
Innovate Shares Gain After FDA Approves Kidney-Function Assessment Device
Shares of Innovate rose after the Food and Drug Administration approved the company's device to assess kidney function. The stock was 43% higher, at $7.30, midday Tuesday, the first day of trading ...
The Thaiger10d
Thai FDA warns against unapproved smart devices for blood sugar
Thai FDA warns against using unapproved smart devices for blood sugar monitoring due to health risks and lack of scientific ...
The 4 Best Red Light Therapy Devices For Hair Growth, According To A Dermatologist And A Beauty Editor
There are crescent-shaped devices, including the Hairmax LaserBand 82, that look similar to extra wide headbands. Because ...
Hometown Source4d
Allina Health Minneapolis Heart Institute first in Minn., Upper Midwest to use new, FDA-approved device to treat persistent atrial fibrillation
Dr. Jay Sengupta, MD, senior cardiologist, AHMHI, and researcher, Minneapolis Heart Institute Foundation (MHIF), successfully ...