FDA launches communications pilot to enhance medical device recall programme
The pilot by the FDA’s CDRH will improve communications about corrective actions being taken over certain medical device ...
News Medical1d
AI-designed drug ISM5939 granted IND clearance for cancer clinical trials
Ins ("Insilico"), a clinical-stage generative artificial intelligence (AI)-driven drug discovery company, announced that it has received IND clearance from FDA for ISM5939, a potential best-in-class ...
Becker's Hospital Review1d
FDA looks to improve communication on high-risk medical device recalls
The FDA's Center for Devices and Radiological Health announced a pilot program designed to improve the timeliness of communications regarding high-risk medical device recalls.
MedPage Today1d
New FDA Panel Weighs In on Regulating Generative AI in Healthcare
The Digital Health Advisory Committee (DHAC) held its first meeting to offer guidance to the FDA on a slew of questions ...
Medical Design and Outsourcing1d
Faster breakthrough device coverage might be on the way
The bipartisan proposal goes further than the Transitional Coverage for Emerging Technologies (TCET) pathway that CMS is ...
medtechdive1d
FDA plan would alert public sooner on high-risk device recalls
The Center for Devices and Radiological Health’s pilot program is meant to cut the time between the FDA’s awareness of ...
MassDevice2d
Johnson & Johnson MedTech’s participation in the Voluntary Improvement Program, supported by FDA
Partner content with ISACA. FDA studies have found that in the medical device industry, compliance alone is not enough to ensure improved quality indicators. Why? Because compliant medical-device ...
MassDevice2d
FDA approves Insightec Exablate Prime for use on Philips systems
Insightec announced today that it received FDA approval and CE mark for its Exablate Prime system with certain Philips MR ...
JD Supra3d
Upcoming FDA Meeting Focuses on Generative AI in Medical Devices
The U.S. Food and Drug Administration will focus on “Total Product Lifecycle Considerations for Generative AI-Enabled Devices” during its ...
Medical Design and Outsourcing3d
FDA to address regulatory challenges for generative AI in medtech
The FDA will discuss a new framework for regulating generative artificial intelligence (GenAI)-enabled medical devices.
FDA approves Omron AI-powered AFib detection in blood pressure monitors
In October 2024, Omron Healthcare received de novo authorisation from the US Food and Drugs Administration (FDA) to market ...
GlobalData on MSN3d
Augmedics’ xvision system registration method gains FDA clearance
Augmedics has received the Food and Drug Administration (FDA) 510(k) clearance of the new CT-to-fluoroscopy (CT-Fluoro) registration method for its xvision spine system. Navigating off using ...