Business Wire October 24, 2023

FDA’s list of AI-enabled device authorizations includes almost 700 devices; 58 are from GE HealthCare – more than any other medical technology company.

CHICAGO–(BUSINESS WIRE)–GE HealthCare has topped a U.S. Food and Drug Administration (FDA) list of artificial intelligence (AI) enabled medical devices with 58 listed 510(k) clearances or authorizations to date in the United States. GE HealthCare also topped the list when it was updated by the FDA in 2022.

AI is central to the company’s digital strategy, which is focused on its precision care framework that includes smart devices, targeted therapies, a disease-specific focus, and digital solutions. Precision care can bring data together in...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

Continue Reading

 
Topics: AI (Artificial Intelligence), FDA, Govt Agencies, Medical Devices, Technology
Related Articles:
Your Earphones And Headphones As Health And Medical Devices
Medtronic, Tempus testing AI to find potential TAVR patients
AI Robot Scanner as Good as Rheumatologists at Assessing RA
Regulatory Hurdles and Ethical Concerns Beset FDA Oversight of AI/ML Devices
From SpaceTech to MedTech: What medical device engineering teams can learn from aerospace

Share This Article