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FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety, Effectiveness, and Quality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 ...
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Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...
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 ...
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 ...
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 ...
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 ...
Business Insider13d
Tempus AI announces national launch of FDA-approved xT CDx test
Tempus AI (TEM) announced the national launch of the company’s FDA-approved, NGS-based in vitro diagnostic device, xT CDx. Beginning today, xT CDx is now available for all ordering clinicians ...