FDA maintains a public registry of AI medical devices. It lists 1,610 entries

The "AI-Enabled Medical Devices" list is not a legal act. The FDA runs it as a registry, a public index of medical devices with an artificial intelligence component that have received clearance for marketing. In mid-September 2026, the page displayed the date "content current as of 09/04/2026," and the table contained 1,610 entries. The oldest entry is dated 15 March 2001. The newest reach early September 2026. In 2026 alone, the agency added 182 decisions.

The list is ordered by the most recent decisions. At the top, dated 29 June 2026, are Auto-Seg (SO-0012), Spine from Agada Medical (number K253628, radiology panel), ADAS 3D from Adas3D Medical (K253969), and the Alturion Series Diagnostic Ultrasound System from Philips Ultrasound (K260667). A day later, the agency cleared SOMNUM from Honeynaps (K253390, neurology panel). On 26 June, it cleared MammoScreen (5) from Therapixel (K260714), a mammography tool.

Further down the table are syngo.CT Coronary Cockpit from Siemens Medical Solutions (K253786, 25 June), Enhanced Boundary for PCCT from GE Medical Systems (K253560, 24 June), and CMN Capillary Function with Oncology Virtual Expert from Cercare Medical (K260316, 22 June). The 18 June decisions include RadOncAI (K253050), ARTHUR (K260190), and Vascular Assist Occlusion Triage (K260729). The registry covers diagnostic models, but also software that supports treatment planning and triage.

What is not on the list yet

The FDA says a future update will separately flag devices that use functions based on large language models. Until then, manufacturers are encouraged to include this information in their public summaries. An entry on the list does not equal full documentation. The agency notes that cleared devices whose decision summary was not published during the data collection period appear in the registry only at the next update.

Advisory committees operate on a separate track. On 23 September 2026, an FDA advisory panel supported the Galleri blood test from Grail, which screens for multiple cancer types. The panel voted 10 to 0 that there is "reasonable assurance" of safety, 6 to 4 that there is reasonable assurance of effectiveness, and 7 to 2 with one abstention that the benefits outweigh the risks in patients meeting the criteria of the proposed indication. The agency does not have to follow a panel's opinion, but it often does.

In clinical practice, the scope of the evidence matters more than the number of entries. The registry states how many devices were cleared. It does not answer whether each one improves treatment outcomes. The public list is a starting point, not the end of the assessment.