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FDA AI-Enabled Device Clearances, Counted

How many AI devices the FDA has listed, by year and specialty, and the newest decisions.

  • The FDA's public list has 1,614 AI-enabled devices. The newest decision on it is dated 06/29/2026.
  • Decisions per year went from 80 in 2019 to 335 in 2025. 2026 is a part year (181 so far).
  • Radiology is 75% of the decisions in the last 12 months on the list.
  • The FDA says the list is not exhaustive. Treat these as a floor, not a full count.

Decisions per year

8020191142020129202116220222262023235202433520251812026*
FDA AI-enabled device list, count by year of final decision. *2026 is partial, up to 06/29/2026. Source: FDA list, our count.

Which specialties, last 12 months

Lead panelDecisionsShare
Radiology25575%
Cardiovascular3410%
Neurology154%
Anesthesiology82%
Gastroenterology-Urology82%
Pathology41%

Window: decisions from 1 July 2025 to 06/29/2026 (340 entries). Panel is the FDA review panel named on the list.

The 40 newest decisions

Decision dateCompanyDevicePanelSubmission
06/29/2026Agada Medical, Ltd.Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)RadiologyK253628
06/29/2026Adas3D Medical S.L.ADAS 3DRadiologyK253969
06/29/2026Philips Ultrasound, LLCAlturion Series Diagnostic Ultrasound SystemRadiologyK260667
06/27/2026Honeynaps Co., Ltd.SOMNUM (SOMNUM)NeurologyK253390
06/26/2026TherapixelMammoScreen® (5)RadiologyK260714
06/25/2026Siemens Medical Solutions USA, Inc.syngo.CT Coronary CockpitRadiologyK253786
06/24/2026Ge Medical Systems, LLCEnhanced Boundary for PCCTRadiologyK253560
06/22/2026Vivaquant, Inc. Dba Rhythm ExpressRX-1 SleepAnesthesiologyK253148
06/22/2026Cercare Medical A/SCMN Capillary Function with Oncology Virtual ExpertRadiologyK260316
06/18/2026InformaiRadOncAIRadiologyK253050
06/18/2026ROPCA ApSARTHURRadiologyK260190
06/18/2026GuideAI HealthVascular Assist Occlusion Triage (VAOT) (v1.0)RadiologyK260729
06/18/2026FUJIFILM Healthcare Americas CorporationSynapse PACS (7.6.0)RadiologyK261713
06/16/2026Siemens Medical Solutions USA, Inc.ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select DiagRadiologyK260844
06/15/2026Crescom Co., Ltd.MediAI-OARadiologyK253172
06/15/2026Siemens Healthineers AGLungMapsRadiologyK253690
06/15/2026DeepHealth, Inc.Saige-DxRadiologyK253825
06/15/2026Anumana, Inc.WatchMate SoftwareRadiologyK260300
06/12/2026Brainomix LimitedBrainomix 360 HyperdensityRadiologyK260406
06/11/2026Mighty Oak MedicalAcorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)RadiologyK260322
06/10/2026Alpha Intelligence Manifolds, Inc.DeepXray SpinaRadiologyK253192
06/08/2026Pathwai, Inc.EchoNextCardiovascularK260332
06/04/2026Covidien, LLCInstrument Exit Point on Touch Surgery™ AideGastroenterology-UrologyK253984
06/04/2026Keya Medical Technology Co., Ltd.DEEPVESSEL PlaqueRadiologyK260497
06/04/2026SonioSonio SuspectRadiologyK261519
06/03/2026Wave NeuroscienceMeRT SystemNeurologyK260402
06/03/2026DeskiHeartFocusRadiologyK260780
06/02/2026Tyto Care , Ltd.Tyto Insights for Wheeze Detection (with PCCP)AnesthesiologyK252844
05/29/2026iRhythm Technologies, Inc.ZEUS Platform (FG0501US)CardiovascularK252859
05/29/2026HistoSonics, Inc.HistoSonics® Planning ToolRadiologyK252947
05/29/2026OrthoGrid Systems, Inc.OrthoGrid Hip AI® 4.0RadiologyK260077
05/29/2026Cosmo Artificial Intelligence - Ai, Ltd.GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)Gastroenterology-UrologyK261369
05/28/2026Imeka Solutions, Inc.ANDI 2.2RadiologyK261405
05/27/2026Fujifilm CorporationSynapse Lung Nodule AIRadiologyK254075
05/27/2026Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound SystemRadiologyK260123
05/27/2026Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic RadiologyK260680
05/22/2026Cardiosense, Inc.PCWP Analysis SoftwareCardiovascularDEN250057
05/22/2026Shanghai United Imaging Healthcare Co., Ltd.uMR AstraRadiologyK260113
05/22/2026Canon Medical Informatics, Inc.Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningRadiologyK260324
05/21/2026Wuhan United Imaging Healthcare Co.,LtduSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita EliteRadiologyK253720

What this does not tell you

The list shows what the FDA authorised, not how a company's software is built or run after clearance. It does not say which companies need engineering help, and we do not claim to know. A device appearing here is not an endorsement by us, and we have no relationship with the companies named.

Method: we counted rows in the FDA's public CSV by final decision date and by lead panel. We did not edit any entries. Counts will change when the FDA updates its list.

Source: FDA, List of AI-Enabled Medical Devices.

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