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 ...
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 ...
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.
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 ...
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 ...
Fierce Healthcare4d
FDA advisory committee to roll up sleeves on generative AI this week
The Food and Drug Administration will hold its first Digital Health Advisory Committee (DHAC) meeting to discuss how the ...
TMCnet2d
FDA Approves Novocure's Innovative HFE Transducer Arrays for Use With Optune Gio® for Glioblastoma
Novocure (NASDAQ: NVCR) announced today that the U.S. Food and Drug Administration (FDA) approved its new Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio® for the treatment of ...