JD Supra4d
Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...
JD Supra11d
FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety, Effectiveness, and Quality
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how ...
The National Law Review7d
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 ...
medtechdive6d
AI in medtech is taking off. Here are 4 trends to watch in 2025.
New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...
Hosted on MSN1d
Caranx Medical submits AI TAVI-TAVR guide software to FDA
TAVIPILOT Soft is said to be a ‘world-first’ provision for real-time surgical guidance during TAVI and TAVR procedures.
STAT7d
New president, new rules: Trump rescinds Biden’s AI order
You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life ...
Modern Healthcare8d
AI in healthcare needs human oversight. Can hospitals keep up?
Despite the AI hype, the systems require consistent monitoring and staffing to put in place and maintain. The process can be ...
Armed robbery in Revesby1h
AI Model Flags Risk Genes for Parkinson's Disease
Researchers from the Cleveland Clinic Genome Center have successfully applied advanced artificial intelligence (AI) genetics ...
US FDA OKs monthly maintenance dosing for Eisai/Biogen's Alzheimer's drug
The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's ...
Avant Technologies to Play Key Role in Ainnova's U.S. FDA Clinical Study for Its Vision AI Platform
Avant Technologies, Inc. (OTCQB: AVAI) ("Avant" or the "Company"), and its partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease ...
FDA approves standalone use of J&J's ketamine-derived depression treatment
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson's nasal spray, Spravato, to allow it to be used ...
IGC Pharma Named Top 15 Finalist in NIA PREPARE Challenge for AI-Driven Early Detection of Alzheimer’s Disease
POTOMAC, MD / ACCESS Newswire / January 28, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") is proud to announce its selection as one of the top 15 finalists in the PREPARE ...