With a Trump-driven reduction of nearly 2,000 employees, agency officials view artificial intelligence as a way to speed ...

In JAMA, the FDA's Makary and Prasad said they will focus on modernizing review processes and lowering drug costs but don't outright mention precision medicine.

A former FDA reviewer offers advice to help innovative medtech avoid new and more dangerous pitfalls as experts leave the ...

The counterfeit drug detection device market is anticipated to be worth USD 1,167.7 million in 2024. The market is expected ...

More and more devices using AI and machine learning technology are becoming available for purchase, something that’s just as ...

Layoffs at the FDA, USDA and CDC could erode the U.S. food safety system. Experts aren’t so worried about milk or chicken today; they’re concerned about the future.

Learn key considerations for data selection for AI-driven MedTech development and how to identify the ideal data sets.

The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool's ...

Regulatory agencies such as the FDA and EMA, as well as many others, set stringent guidelines for safety labeling. These guidelines are designed to ensure that safety information is communicated ...

The medical device industry faces increasing regulatory complexity, leading to long delays in registration and market entry. These timelines not only slow patient access to life-saving devices but ...