{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,6]],"date-time":"2026-02-06T00:21:23Z","timestamp":1770337283499,"version":"3.49.0"},"reference-count":0,"publisher":"IOS Press","isbn-type":[{"value":"9781643686080","type":"electronic"}],"license":[{"start":{"date-parts":[[2025,8,7]],"date-time":"2025-08-07T00:00:00Z","timestamp":1754524800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,8,7]]},"abstract":"<jats:p>The U.S. Food and Drug Administration (FDA) plays an important role in ensuring safety and effectiveness of AI\/ML-enabled devices through its regulatory processes. In recent years, there has been an increase in the number of these devices cleared by FDA. This study analyzes 104 FDA-approved ML-enabled medical devices from May 2021 to April 2023, extending previous research to provide a contemporary perspective on this evolving landscape. We examined clinical task, device task, device input and output, ML method and level of autonomy. Most approvals (n = 103) were via the 510(k) premarket notification pathway, indicating substantial equivalence to existing devices. Devices predominantly supported diagnostic tasks (n = 81). The majority of devices used imaging data (n = 99), with CT and MRI being the most common modalities. Device autonomy levels were distributed as follows: 52% assistive (requiring users to confirm or approve AI provided information or decision), 27% autonomous information, and 21% autonomous decision. The prevalence of assistive devices indicates a cautious approach to integrating ML into clinical decision-making, favoring support rather than replacement of human judgment.<\/jats:p>","DOI":"10.3233\/shti250993","type":"book-chapter","created":{"date-parts":[[2025,8,7]],"date-time":"2025-08-07T11:37:31Z","timestamp":1754566651000},"source":"Crossref","is-referenced-by-count":1,"title":["Role of AI in Clinical Decision-Making: An Analysis of FDA Medical Device Approvals"],"prefix":"10.3233","author":[{"given":"Poorna","family":"Fernando","sequence":"first","affiliation":[{"name":"Australian Institute of Health Innovation, Faculty of Medicine, Health and Human Sciences, Macquarie University, Australia"},{"name":"Ministry of Health, Sri Lanka"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Lyell","sequence":"additional","affiliation":[{"name":"Australian Institute of Health Innovation, Faculty of Medicine, Health and Human Sciences, Macquarie University, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying","family":"Wang","sequence":"additional","affiliation":[{"name":"Australian Institute of Health Innovation, Faculty of Medicine, Health and Human Sciences, Macquarie University, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Farah","family":"Magrabi","sequence":"additional","affiliation":[{"name":"Australian Institute of Health Innovation, Faculty of Medicine, Health and Human Sciences, Macquarie University, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"7437","container-title":["Studies in Health Technology and Informatics","MEDINFO 2025 \u2014 Healthcare Smart \u00d7 Medicine Deep"],"original-title":[],"link":[{"URL":"https:\/\/ebooks.iospress.nl\/pdf\/doi\/10.3233\/SHTI250993","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,7]],"date-time":"2025-08-07T11:37:31Z","timestamp":1754566651000},"score":1,"resource":{"primary":{"URL":"https:\/\/ebooks.iospress.nl\/doi\/10.3233\/SHTI250993"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,7]]},"ISBN":["9781643686080"],"references-count":0,"URL":"https:\/\/doi.org\/10.3233\/shti250993","relation":{},"ISSN":["0926-9630","1879-8365"],"issn-type":[{"value":"0926-9630","type":"print"},{"value":"1879-8365","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,7]]}}}