FDA’s AI Tool for Medical Devices Faces Performance Setbacks
The U.S. Food and Drug Administration (FDA) is under scrutiny after internal sources revealed that its latest AI tool, designed to assist with the review of medical devices, is plagued with technical shortcomings. The system, called CDRH-GPT, is currently in beta testing and intended to help the Center for Devices and Radiological Health (CDRH) streamline…