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 ...
Breakthrough technology for human muscle fatigue measure, Myocene, gets FDA "de novo" approval.
Myocene, the Belgian sportstech company specializing in innovative muscle fatigue assessment announced today that its groundbreaking device for "providing objective measures of muscle fatigue to ...
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 ...
Pharm Exec3d
Challenges to Navigating the Pharmaceutical Regulatory Landscape
In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...
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 ...
JD Supra1d
International AI Regulatory Contrast: Evolving frameworks in the EU, UK, and US
In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...
Neuralink Explained: Musk’s Quest For Brain-Machine Interfaces
Neuralink’s brain-computer interface technology also has been discussed for other potential uses, for example, in mental health treatments for anxiety, depression or post-traumatic stress disorder ...