The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...

(click to enlarge)A potential organizational structure for FDA's Sentinel initiative. It can take a long time for FDA to piece together medical device reports (MDRs) and other data to determine that ...

The number of medical devices with artificial intelligence technology has risen sharply in the past decade. The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices ...

This study examines the availability of cost-effectiveness analyses for medical devices, both in terms of the number of studies and when studies are published. Objectives: Academic researchers and ...