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 ...
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 ...
Edmonds woman calls newly approved spinal cord treatment a 'milestone moment' in recovery
UW Medicine is unveiling an FDA-approved spinal cord therapy in an effort to offer new hope for paralyzed patients.
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 ...
조선일보7d
KFDA sets global standard for generative AI medical device approval guidelines
KFDA sets global standard for generative AI medical device approval guidelines Health authority introduces pioneering ...
federalnewsnetwork.com2d
FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
GlobalData on MSN1d
Aethlon Medical treats first subject with Hemopurifier device in Australia
"Aethlon Medical treats first subject with Hemopurifier device in Australia" was originally created and published by Medical ...
JD Supra4h
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 ...
The Hacker News11h
CISA and FDA Warn of Critical Backdoor in Contec CMS8000 Patient Monitors
Unpatched vulnerabilities in Contec CMS8000 patient monitors expose devices to remote access, file overwrites, and data leaks ...
JD Supra9d
FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...