FDA launches list of AI and machine learning-enabled medical devices
By EsqSocial Corporation 24/09/21
Yesterday, the U.S. Food and Drug Administration (FDA) shared online its list of artificial intelligence and machine learning (AI/ML)-enabled devices that are legally marketed in the U.S. (via 510(k) clearance, De Novo authorization, or Premarket (PMA) approval). The agency’s newly-minted Digital Health Center of Excellence developed this non-comprehensive list to increase transparency and access to information on AI/ML-based medical devices and FDA’s work in the space. The effort comes...
By: Hogan Lovells