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 ...
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 ...
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 ...
medtechdive9d
FDA breakthrough device decisions rebound after recent declines
The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the ...
Newsweek17d
RFK Jr. Says Entire FDA Departments 'Have To Go'
Kennedy Jr. has said he will clear out "entire departments" of the U.S. Food and Drug Administration (FDA ... biological products, medical devices, food and cosmetics. RFK Jr. is an outspoken ...
FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDADENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- ...
pharmaphorum18d
Patient feedback is creating next-gen drug delivery devices
The patient voice has grown in importance, and now it is being applied to develop and deliver more sophisticated drug delivery devices. Ben Hargreaves finds that connected devices can now provide ...