Recently cleared AI devices
The most recent AI-enabled device on the FDA list is Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) from Agada Medical, Ltd., decided on June 29, 2026. These are the 100 latest decisions, grouped by month.
AI Device Radar Weekly
New FDA AI clearances, every week
A short email when a new issue is published: the devices the FDA just decided, the companies behind them, and what changed in the counts. Read the archive.
June 2026 · 28 shown
- Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)Agada Medical, Ltd. · Radiology
- ADAS 3DAdas3D Medical S.L. · Radiology
- Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- SOMNUM (SOMNUM)Honeynaps Co., Ltd. · Neurology
- MammoScreen® (5)Therapixel · Radiology
- syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · Radiology
- Enhanced Boundary for PCCTGe Medical Systems, LLC · Radiology
- RX-1 SleepVivaquant, Inc. Dba Rhythm Express · Anesthesiology
- CMN Capillary Function with Oncology Virtual ExpertCercare Medical A/S · Radiology
- RadOncAIInformai · Radiology
- ARTHURROPCA ApS · Radiology
- Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI Health · Radiology
- Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · Radiology
- ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · Radiology
- MediAI-OACrescom Co., Ltd. · Radiology
- LungMapsSiemens Healthineers AG · Radiology
- Saige-DxDeepHealth, Inc. · Radiology
- WatchMate SoftwareAnumana, Inc. · Radiology
- Brainomix 360 HyperdensityBrainomix Limited · Radiology
- Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · Radiology
- DeepXray SpinaAlpha Intelligence Manifolds, Inc. · Radiology
- EchoNextPathwai, Inc. · Cardiovascular
- Instrument Exit Point on Touch Surgery AideCovidien, LLC · Gastroenterology-Urology
- DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd. · Radiology
- Sonio SuspectSonio · Radiology
- MeRT SystemWave Neuroscience · Neurology
- HeartFocusDeski · Radiology
- Tyto Insights for Wheeze Detection (with PCCP)Tyto Care , Ltd. · Anesthesiology
May 2026 · 33 shown
- ZEUS Platform (FG0501US)iRhythm Technologies, Inc. · Cardiovascular
- HistoSonics® Planning ToolHistoSonics, Inc. · Radiology
- OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc. · Radiology
- GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd. · Gastroenterology-Urology
- ANDI 2.2Imeka Solutions, Inc. · Radiology
- Synapse Lung Nodule AIFujifilm Corporation · Radiology
- EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC · Radiology
- PCWP Analysis SoftwareCardiosense, Inc. · Cardiovascular
- uMR AstraShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningCanon Medical Informatics, Inc. · Radiology
- uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace EliteWuhan United Imaging Healthcare Co.,Ltd · Radiology
- BACDeepHealth, Inc. · Radiology
- MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S. · Radiology
- DeepView AI® Systemspectralmd, inc. · General and Plastic Surgery
- Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation · Radiology
- Embryo PredictAlife Health · Obstetrics and Gynecology
- Neurophet SCALE PETNeurophet., Inc. · Radiology
- uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus SuperWuhan United Imaging Healthcare Co.,Ltd · Radiology
- SubtleHD-CT (1.x)Subtle Medical, Inc. · Radiology
- Neurophet AQUANeurophet., Inc. · Radiology
- UNiD Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic) · Radiology
- SubtleHD-PET (1.x)Subtle Medical, Inc. · Radiology
- BriefCase-TriageAidoc Medical , Ltd. · Radiology
- MorphBeauBrain Healthcare, Inc. · Radiology
- RayvolveAZmed · Radiology
- Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc. · Radiology
- LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd. · Dental
- Veritas Reverse Total Shoulder SystemRestor3D · Orthopedic
- Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- MammoSightAINeurocareai, Inc. (Dba Savelife.Ai) · Radiology
- ArteraAI BreastArtera, Inc. · Pathology
- Capnostream35 Portable Respiratory Monitor (PM35MN)Covidien, LLC · Anesthesiology
April 2026 · 28 shown
- Bayesian Health Sepsis Flagging DeviceBayesian Health, Inc. · General Hospital
- Intelligent NRCanon, Inc. · Radiology
- Synapse 3D Base Tools (V7.2)Fujifilm Corporation · Radiology
- DeepHealth ProstateAIQuantib B.V. · Radiology
- syngo Application SoftwareSiemens Medical Solutions USA, Inc. · Radiology
- CASSIEWesper, Inc. · Anesthesiology
- OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)ABBOTT MEDICAL · Radiology
- Lunit INSIGHT MMG (v1.1.10)Lunit, Inc. · Radiology
- DS Core CBCT AnatomyDentsply Sirona · Radiology
- uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd. · Radiology
- EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd. · Radiology
- myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)Otto Bock Healthcare Products GmbH · Neurology
- FolliscanMim Fertility · Radiology
- EdgeFlow UW20Edgecare, Inc. · Radiology
- Novasight Hybrid SystemConavi Medical, Inc. · Cardiovascular
- Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC · Radiology
- DeepBT Detector-PlusAitewan Biomedical Technology, Inc. · Radiology
- AI-Rad Companion Organs RTSiemens Healthcare GmbH · Radiology
- Relu CloudRelu BV · Radiology
- syngo Dynamics (VA41F)Siemens Healthcare GmbH · Radiology
- Overjet Iris Intelligent Imaging SystemOverjet, Inc. · Radiology
- TRIOS Dx (R1)3Shape TRIOS A/S · Dental
- Seaman Pro/SeamanCheckcells, Inc. · Hematology
- ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc. · Cardiovascular
- 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A. · Radiology
- uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd. · Gastroenterology-Urology
- CoLumbo C-SpineSmart Soft Healthcare AD · Radiology
March 2026 · 11+ shown
- AiORTA - Plan v2.0ViTAA Medical Solutions, Inc. · Radiology
- ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc. · Cardiovascular
- Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd. · Radiology
- Butterfly Gestational Age ToolButterfly Network, Inc. · Radiology
- Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology
- EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · Radiology
- S-scan Open (100001800)Esaote, S.p.A. · Radiology
- Contour ProtégéAI+Mim Software, Inc. · Radiology
- Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc. · Neurology
- Lunit INSIGHT DBT (V1.2)Lunit, Inc. · Radiology