U.S. Food and Drug Administration (FDA)

The FDA releases landmark draft guidance for AI-enabled medical devices, offering manufacturers a roadmap for development, approval, and lifecycle management while addressing critical concerns of transparency and demographic bias.

Medical device giant Becton, Dickinson to pay $175M SEC fine for concealing safety risks of its Alaris infusion pump, which generated 10% of company revenues. FDA clearance issues and software problems threatened future sales.

The FDA has overhauled its medical device tracking system, streamlining how manufacturers identify everything from pacemakers to surgical robots in a global database refresh.

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) is launching a pilot program to help speed the release of news and information regarding potentially high-risk medical devices.

The U.S. Food and Drug Administration (FDA) has published its final guidance on its third-party review program and its third-party emergency use authorization (EUA) review process.

The U.S. Food and Drug Administration (FDA) has released a helpful glossary of commonly used terms in connection with digital health devices and medical devices that use artificial intelligence (AI) or machine learning.

The FDA has classified a radiofrequency-based electric toothbrush as a medical device, establishing regulations to ensure the safety and effectiveness of this emerging dental technology.

The Center for Devices and Radiological Health at the U.S. Food and Drug Administration has published an extensive list of guidance documents that it intends to publish or develop in fiscal year 2025.

The FDA released draft guidance on chemical analysis for medical device biocompatibility assessment. This approach can reduce testing time and animal testing. Public comments are accepted until November 19th through the Federal Rulemaking Portal.

The U.S. Food and Drug Administration has updated its list of authorized medical devices that incorporate augmented reality (AR) and virtual reality (VR) technologies.