Sammy Chouffani El Fassi, Adonis Abdullah, Ying Fang, Sarabesh Natarajan, Awab Bin Masroor, Naya Kayali, Simran Prakash, Gail E Henderson
Nat Med . 2024 Aug 26. doi: 10.1038/s41591-024-03203-3. Online ahead of print.
Devices that lack adequate clinical validation pose risks for patient care. A new validation standard is proposed to evaluate FDA authorization as an indication of clinical effectiveness in medical AI.