Study reveals a gap FDA approval AI radiology devices with only 29% undergoing clinical testing before clearance.

By reframing security as an investment rather than a cost, MDMs can reduce risk exposure, improve compliance readiness, and ...

FDA Section 524B transformed medical device cybersecurity from guidance to law, challenging small medtech firms with ...

The Food and Drug Administration is requesting public comment to get feedback on current, practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real ...

FDA has expanded its early alert pilot program to cover all medical devices, according to a September 29 notice. In November 2024, the FDA’s Center for Devices and Radiological Health launched the ...

Please provide your email address to receive an email when new articles are posted on . Essilor Stellest is the first FDA-approved eyeglass lens for myopia control approved for U.S. sale. At 24 months ...

Medication abortion is used in nearly two-thirds of abortions in the U.S. Health and Human Services Secretary Robert F. Kennedy Jr. told Republican states this week that the FDA would conduct a new ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The FDA will convene its Digital Health Advisory Committee Nov. 6 to discuss the use of generative artificial intelligence-based digital mental health medical devices. The virtual meeting, scheduled ...

Sept 11 (Reuters) - The U.S. Food and Drug Administration will hold an advisory panel meeting in November to examine the fast-emerging class of AI-enabled digital mental health devices. The agency's ...

Patient groups called for substantial changes to medical device user fees in comments submitted to the Food and Drug Administration. Negotiations recently kicked off for the medical device user fee ...

Sept 5 (Reuters) - The U.S. Food and Drug Administration is tightening oversight of imports of GLP-1 drug ingredients, used for weight loss and diabetes, amid concerns that many of the items may be ...