Benefit-Risk Reporting for FDA-Cleared Artificial Intelligence-Enabled Medical Devices.
PMID: 41004181 ·
J, o, h, n, , C, , L, i, n, ;, , B, h, a, v, , J, a, i, n, ;, , J, a, y, , M, , I, y, e, r, ;, , I, s, h, a, n, , R, o, l, a, ;, , A, n, u, s, h, a, , R, , S, r, i, n, i, v, a, s, a, n, ;, , C, h, a, e, r, i, m, , K, a, n, g, ;, , H, e, t, a, , P, a, t, e, l, ;, , R, a, v, i, , B, , P, a, r, i, k, h
Реклама
Аннотация
Devices enabled by artificial intelligence (AI) and machine learning (ML) are increasingly used in clinical settings, but there are concerns regarding benefit-risk assessment and surveillance by the US Food and Drug Administration (FDA). To characterize pre- and postmarket efficacy, safety, and risk assessment reporting for FDA-cleared AI/ML devices. This was a cross-sectional study using linked data from FDA decision summaries and approvals databases, the FDA Manufacturer and User Facility Devi
Реклама
Официальный источник
Открыть в PubMed →Данные получены из PubMed / NCBI. Полный текст и наиболее актуальную информацию всегда смотрите в официальной записи.