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.
medtechdive4d
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 ...
JD Supra2d
Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...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 Review5d
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 ...
JD Supra6d
FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
STAT5d
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 Healthcare7d
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 ...
MassDevice5d
Trump is back: Here’s what his initial actions mean for medtech
President Donald Trump has swiftly announced a series of executive orders that could impact the medech industry.
Hosted on MSN11d
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.
Robotic dog helps those facing mental health and cognitive challenges
A U.S. robotics company has developed Jennie, a robotic pet powered by artificial intelligence that's designed to comfort ...
Business Insider12d
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 ...