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.

What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.

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 ...

A group of 211 international experts from 79 countries has published a new framework to facilitate the design, development ...

Experts highlighted surgical robotics, artificial intelligence and M&A as top trends this year. However, the Trump administration could create challenges for the industry.

Pharmapack wrapped up last week with two full days of new product innovation, networking, and informative talks, sessions, ...

Vertex Pharmaceuticals won approval from the U.S. Food and Drug Administration for a non-opioid pain drug, clearing the way for the rollout of a product that has simultaneously sparked high hopes and ...

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source ...