The U.S. Food and Drug Administration (FDA) has now cleared 1,247 clinical artificial intelligence (AI) algorithms for direct patient care. The FDA updated its AI-enabled device approval list this week, which showed the regulatory agency is seeing rapidly increasing numbers of AI product submissions. More than 1,000 of these are specific to medical imaging, with radiology accounting for the majority—over 900 cleared algorithms. Cardiology has the second-highest number, with 116 (or a total of 184 if including cardiac-specific imaging AI listed under radiology). Neurology ranks a distant third with 56 algorithms, many of which are image-based and used for detailed diagnostic assessment or procedural planning.
Read the full article: The FDA Has Cleared More Than 1,200 Clinical AIs—and Submissions Are Increasing //
Source: https://healthexec.com/topics/artificial-intelligence/fda-has-cleared-more-1200-clinical-ais-and-submissions-are-increasing