SaMD Cleared by the FDA: The Ultimate Running List

Randy Horton
Randy Horton

This list, created by Orthogonal and SaMD consultants Brian Binkowski and Ritam Priya contains information on 603 individual Software as a Medical Devices (SaMD) cleared by the FDA. The data used to create this list was pulled from publicly available sources such archived reports from the FDA, Orca1 DI and Basil System’s regulatory search tools. As this list is a work in progress, we invite members of the MedTech and digital health industries to submit comments and revisions in order to improve its accuracy. Submit comments via this form or email us at [email protected].

Learn about the methodology used to create this list by reading our accompanying blog.

List of FDA-Cleared SaMD

CompanyDeviceDate of Final DecisionPanel (Lead)
Odin Medical LimitedCADDIE07/24/2024Gastroenterology/Urology

AgileMD, InceCARTv5 Clinical Deterioration Suite (“eCART”)06/21/2024Cardiovascular
CamDiab Ltd.CamAPS FX05/23/2024Clinical Chemistry
Curio Digital Therapeutics Inc.MamaLift Plus04/22/2024Neurology
prenosis, inc.Sepsis ImmunoScore04/02/2024Gastroenterology/Urology

Otsuka America Pharmaceutical, Inc.Rejoyn03/30/2024Neurology
Clew Medical Ltd.CLEWICU System01/13/2024Cardiovascular
Imvaria, IncFibresolve01/12/2024Radiology
Darmiyan, Inc.BrainSee01/11/2024Neurology
Stryker InstrumentsSurgiCount+ System01/11/2024General & Plastic Surgery
TechsoMed Medical Technologies LtdBioTraceIO Lite12/22/2023Radiology
Qure.Ai TechnologiesqXR-LN12/22/2023Radiology
Fitbit LLCBody Temperature Software (BTS)12/15/2023General Hospital
VideaHealth, Inc.Videa Dental Assist12/15/2023Radiology
Ankon Technologies Co., LtdNaviCam ProScan12/12/2023Gastroenterology/Urology
Voluntis SA.Insulia Bolus Companion12/12/2023General Hospital
Clearpoint Neuro, Inc.Clearpoint System (Software Version 2.2)11/27/2023Neurology
Brainomix LimitedBrainomix 360 Triage Stroke11/21/2023Radiology
Software Nemotec S.L.Nemocast11/21/2023Dental
Exo IncAi Platform (Aip001)11/17/2023Radiology
Axial Medical Printing LimitedAxial3D Insight11/15/2023Radiology
Aidoc Medical, Ltd.Briefcase-Quantification11/13/2023Radiology
Clarius Mobile Health Corp.Clarius Bladder AI11/13/2023Radiology
Aidoc Medical, Ltd.Briefcase-Quantification11/8/2023Radiology
Mim Software, Inc.Contour ProtegeAI11/8/2023Radiology
Lunit Inc.Lunit Insight Dbt11/6/2023Radiology
Carlsmed, IncAprevo® Digital Segmentation11/3/2023Radiology
Airs Medical Inc.SwiftMR10/27/2023Radiology
Implicity Inc.Signalhf (Im008)10/25/2023Cardiovascular
Siemens Medical Solutions USA, IncAI-Rad Companion Brain MR10/23/2023Radiology
Ontact Health Co., Ltd.Sonix Health10/20/2023Radiology
Insulet CorporationSmartbolus Calculator10/18/2023Clinical Chemistry
Clearadvance, LLCTitan Dental Design10/13/2023Dental
EigenArtemis, Artemis Tpo, Artemis Mx10/12/2023Radiology
Sparrow Acoustics Inc.Stethophone10/12/2023Cardiovascular
Avicena, LLCVivio® LVEDP System10/6/2023Cardiovascular
Denti.AI Technology, Inc.Denti.AI Detect10/6/2023Radiology
Intelligent Ultrasound LimitedScannav Anatomy Peripheral Nerve Block10/6/2023Anesthesiology
DeepTek Medical Imaging Pvt LtdDeepTek CXR Analyzer v1.010/5/2023Radiology
Curemetrix, Inc.Cmangio® V1.010/5/2023Radiology
Vuno Inc.Vuno Med-Deepbrain10/4/2023Radiology
Imagen Technologies, IncLung-CAD10/3/2023Radiology
Terran Biosciences, Inc.Terran Nm-1019/29/2023Radiology
Brainomix LimitedBrainomix 360 Triage LVO9/28/2023Radiology
Anumana, Inc.Low Ejection Fraction AI-ECG Algorithm9/28/2023Cardiovascular
Ai Medical AGJazz9/22/2023Radiology
Rology Inc.Rology Teleradiology Platform (V.1.22.1103)9/20/2023Radiology
Impact Applications, Inc.Impact Version 49/16/2023Neurology
Imagen Technologies, IncLung-CAD9/13/2023Radiology
Cleerly, IncCleerly Ischemia9/8/2023Cardiovascular
Convergent Imaging SolutionsUnisyn Molecular Imaging (6-3-1)9/1/2023Radiology
TechsomedVisable.Io8/28/2023Radiology
AIRAmed GmbHAIRAscore8/25/2023Radiology
ICU Medical, IncLifeShield™ Infusion Safety Software Suite8/24/2023General Hospital
Natural Cycles Nordic ABNatural Cycles8/24/2023Obstetrics/Gynecology
Depuy Orthopaedics, IncCUPTIMIZE™ Advanced8/22/2023Radiology
CochlearCochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App8/18/2023Ear Nose & Throat
Spark Neuro Inc.Spark Scan8/18/2023Neurology
Ever Fortune.Ai Co., Ltd.Efai PACS Picture Archiving And Communication System Pro8/8/2023Radiology
Viz.Ai, Inc.Viz HCM8/3/2023Cardiovascular
Imidex Inc.VisiRad XR8/3/2023Radiology
Welldoc, Inc.Bluestar And BlueStar Rx7/28/2023Clinical Chemistry
Brainomix LimitedBrainomix 360 Triage ICH7/27/2023Radiology
SonioSonio Detect7/25/2023Radiology
Imeka Solutions, Inc.Andi7/25/2023Radiology
UltraSight Inc.UltraSight AI Guidance7/24/2023Radiology
Rebrain, SasOptimMRI7/21/2023Radiology
Apple Inc.Irregular Rhythm Notification Feature (Irnf)7/21/2023Cardiovascular
Shanghai United Imaging Healthcare Co., Ltd.Uomnispace7/20/2023Radiology
Siemens Healthcare GmbHSyngo.Ct Lung CAD (Version Vd30)7/19/2023Radiology
Rgorithm KoreaTrust7/18/2023Dental
Brainlab AgBrainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);Bold MRI Mapping (1.0);Image Fusion Angio (1.0)7/14/2023Radiology
Visus Health It GmbHJivex (Model Number / Release: 5.4)7/14/2023Radiology
Better TherapeuticsBT-0017/7/2023Clinical Chemistry
Etiometry, Inc.T3 Platform Software7/7/2023Cardiovascular
Medical Metrics, Inc.Spine Camp™ (1.1)7/7/2023Radiology
Axial Medical Printing LimitedAxial3D Insight7/3/2023Radiology
Renalytix AI, Inc.KidneyIntelX.Dkd6/29/2023Clinical Chemistry
GPI USA, Inc.Blood Establishment Computer Software And Accessories6/26/2023Hematology
Exo IncBladder Ai (Aibv01)6/22/2023Radiology
Thorasys Thoracic Medical Systems, Inc.Tremoflo C2 Airwave Oscillometry System6/20/2023Anesthesiology
Resonance Health Analysis Services Pty LtdHepafatsmart (V2.0.0)6/20/2023Radiology
Eyenuk, IncEyeArt v2.2.06/16/2023Ophthalmic
Medicalip Co., LtdDeepcatch6/16/2023Radiology
Ib Lab GmbHIb Lab Lama6/16/2023Radiology
Shanghai Ea Medical Instruments Co., Ltd.Iortho6/13/2023Dental
Imbio, Inc.Cac Software6/13/2023Radiology
Ablacon, Inc.Ablamapâ® System6/8/2023Cardiovascular
Feops NvFEops HEARTguideTM, FEops HEARTguideTM ALPACA6/6/2023Radiology
Medopad IncHuma RPM (RPM)6/2/2023Cardiovascular
Ge Medical Systems, LLCCritical Care Suite With Pneumothorax Detection Ai Algorithm, Critical Care Suite 2.1, Critical Care Suite5/25/2023Radiology
Hologic, Inc.Genius Ai Detection 2.0 With Cc-Mlo Correlation5/23/2023Radiology
Adas3D Medical S.LAdas 3D5/23/2023Radiology
Cedars-Sinai Medical CenterAutoplaque5/19/2023Radiology
Deepx Health LLCDeepx Dermosight Dermatoscope5/17/2023General & Plastic Surgery
Subtle Medical Inc.Subtlemr (2.3.X)5/11/2023Radiology
Swing Therapeutics, IncStanza5/9/2023Neurology
Ge Medical Systems, LLCAuto Segmentation5/4/2023Radiology
Samsung Electronics Co., LtdSamsung ECG Monitor Application With Irregular Heart Rhythm Notification5/2/2023Cardiovascular
Surgical Information Sciences, Inc.Sis System5/2/2023Radiology
Medapp S.A.Carnalife Holo5/1/2023Radiology
Ceevra, Inc.Ceevra Reveal 34/25/2023Radiology
Bunkerhill, IncICAC Device4/25/2023Radiology
Elaitra LtdViewfinder Software Version 1.14/21/2023Radiology
TherapanaceaArt-Plan4/19/2023Radiology
Radformation, Inc.Autocontour Model Radac V34/14/2023Radiology
Yukun (Beijing) Technology Co., LtdCerebralgo Plus4/13/2023Radiology
Ezra Ai, Inc.Ezra Flash4/13/2023Radiology
Limbus Ai Inc.Limbus Contour4/7/2023Radiology
Mim Software, Inc.Contour ProtegeAI4/6/2023Radiology
Masimo CorporationMasimo SafetyNet3/31/2023Anesthesiology
Formus Labs, LtdFormus Hip3/31/2023Radiology
Baxter Healthcare CorporationSpectrum IQ Infusion System with Dose IQ Safety Software3/31/2023General Hospital
Mediso Medical Imaging Systems, Lttd.Interview XP; Interview Fusion3/29/2023Radiology
Nobel Biocare ABDTX Studio Clinic 3.03/28/2023Radiology
SynapsicaRadiolens V1.03/28/2023Radiology
Medipixel, Inc.Mpxa-20003/22/2023Radiology
GNC Holdings, LLCDigital Routines3/15/2023General Hospital
Manteia Technologies Co., Ltd.Accucontour3/9/2023Radiology
GleamerBoneview3/2/2023Radiology
iSchemaView Inc.Rapid Ncct Stroke3/2/2023Radiology
Arteryflow Technology Co., Ltd.AccuFFRangio Plus3/2/2023Radiology
Arteryflow Technology Co., Ltd.AccuICAS2/28/2023Radiology
Caption HealthCaption Interpretation Automated Ejection Fraction Software2/24/2023Radiology
Tyto Care Ltd.Tytocare Lung Sounds Analyzer2/24/2023Anesthesiology
Brainomix LimitedBrainomix 360 E-Aspects2/23/2023Radiology
Radiopharmaceutical Imaging And Dosimetry, LLC3D-RD-S2/22/2023Radiology
MRIguidance B.VBoneMRI V1.62/22/2023Radiology
Medasense Biometrics Ltd.PMD-2002/17/2023Anesthesiology
Videahealth, IncVidea Perio Assist2/6/2023Radiology
Prolira B.V.Deltascan Monitor2/2/2023Neurology
Atomica Technology, Inc.Atomica Planner2/2/2023Radiology
Goldenear Company, Inc.Tinnitogram Signal Generator2/1/2023Ear Nose & Throat
Dia Imaging Analysis LtdLvivo IQS2/1/2023Radiology
iSchemaView Inc.Rapid Rv/Lv2/1/2023Radiology
Quanta Computer Inc.Qoca Image Smart Cxr Image Processing System1/27/2023Radiology
Sim&CureSim&Size1/27/2023Neurology
Tidepool ProjectTidepool Loop1/23/2023Clinical Chemistry
Clarius Mobile Health Corp.Clarius AI1/23/2023Radiology
Etiometry, Inc.T3 Platform Software1/6/2023Cardiovascular
Coreline Soft Co.,Ltd.Aview12/23/2022Radiology
Deephealth, Inc.Saige-Density12/16/2022Radiology
Hyperfine, Inc.Braininsight12/16/2022Radiology
Rhythm Al, LtdStar Apollo Mapping System12/1/2022Cardiovascular
Ultromics Ltd.Echogo Heart Failure11/23/2022Cardiovascular
Avenda Health, Inc.Avenda Health AI Prostate Cancer Planning Software11/22/2022Radiology
Surgical Information Sciences, Inc.Sis System (Version 5.6.0)11/21/2022Radiology
MRIguidance B.VBoneMRI V1.411/16/2022Radiology
Siemens Medical Solutions USA, IncSyngo Dynamics (Version Va40F)11/14/2022Radiology
AEYE Health, Inc.AEYE-DS11/10/2022Ophthalmic
Luminopia, Inc.Luminopia One11/4/2022Ophthalmic
Welch Allyn Inc.Welch Allyn Connex Central Station10/28/2022Cardiovascular
Shanghai United Imaging Healthcare Co., Ltd.UMR Omega With uWS-MR-MRS10/27/2022Radiology
Xironetic, LLCIntraop Vsp Software Device10/21/2022Radiology
Medical Metrics, Inc.Spine Camp™10/18/2022Radiology
Heartflow, Inc.Heartflow Analysis10/14/2022Cardiovascular
Siemens Medical Solutions USA, IncAI-Rad Companion Organs Rt10/14/2022Radiology
Hologic, Inc.Genius Ai Detection 2.010/6/2022Radiology
Diagnostic Grifols, S. A.Blood Establishment Computer Software And Accessories10/4/2022Hematology
Casis Cardiac Simulation & Imaging SoftwareQIR Suite9/30/2022Radiology
Medcognetics, Inc.Cognet Qmtriage9/29/2022Radiology
Novasight Ltd.Curesight-Cs1009/29/2022Ophthalmic
Neosoma Inc.Ns-Hglio9/27/2022Radiology
Neumetry Medical IncSomnometry9/21/2022Neurology
Imagen Technologies, IncAorta-CAD9/20/2022Radiology
Neuro-Eye Diagnostic Systems LLCEyeCTester9/7/2022Ophthalmic
Baxter Healthcare CorporationDose IQ Safety Software8/30/2022General Hospital
Viz.Ai, Inc.Viz Rv/Lv8/29/2022Radiology
Spectronic Medical ABMRI Planner8/25/2022Radiology
Radformation, Inc.Autocontour Model Radac V28/24/2022Radiology
Siemens Medical Solutions USA, IncMI View&Go8/19/2022Radiology
PathAI, INC.Novo8/11/2022Pathology
Clearpoint Neuro, Inc.Clearpoint Maestro Brain Model8/8/2022Radiology
Screenpoint Medical B.V.Transpara 1.7.28/3/2022Radiology
3D-Side SACustomize8/3/2022Radiology
Circle Cardiovascular Imaging IncCvi42 Auto Imaging Software Application7/28/2022Radiology
Cochlear AmericasCochlear Osia 2 System, Cochlear Osia Osi200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit7/27/2022Ear Nose & Throat
Ge Medical Systems Ultrasound And Primary Care Diagnostics,Echopac Software Only, Echopac Plug-In7/22/2022Radiology
Dyad Medical, IncLibby Echo:Prio7/20/2022Radiology
iRhythm Technologies, Inc.Zeus System (Zio Watch)7/19/2022Cardiovascular
Hyperfine, Inc.Braininsight7/19/2022Radiology
Siemens Medical Solutions USA, IncNaeotom Alpha, Scan&Go Software7/12/2022Radiology
Scanmed, LLCProstatid7/8/2022Radiology
Eko Devices IncEko Murmur Analysis Software (EMAS)6/29/2022Cardiovascular
Cascination AgOtoplan6/24/2022Ear Nose & Throat
Smart Soft Healthcare AdColumbo6/23/2022Radiology
Etiometry, Inc.T3 Platform Software6/22/2022Cardiovascular
Digital Diagnostics IncIDx-DR v2.36/17/2022Ophthalmic
TherapanaceaArt-Plan6/17/2022Radiology
EarliTec Diagnostics, Inc.EarliPoint System

06/08/2022Neurology
Visicu, Inc.eCareManager 4.56/3/2022Cardiovascular
Apple Inc.Atrial Fibrillation History Feature6/3/2022Cardiovascular
Azmed SasRayvolve6/2/2022Radiology
Ever Fortune.Ai Co., Ltd.Efai Cardiosuite Spect Myocardial Perfusion Agile Workflows5/31/2022Radiology
iSchemaView Inc.Rapid Lvo5/31/2022Radiology
Airs Medical Inc.SwiftMR5/25/2022Radiology
3D Ons, Inc.On3D5/23/2022Radiology
Deephealth, Inc.Saige-Dx5/12/2022Radiology
Overject Inc.Overjet Caries Assist5/10/2022Radiology
MVision AIMVision AI Segmentation5/3/2022Radiology
Ever Fortune.Ai Co., Ltd.Efai RTsuite Ct Hn-Segmentation System4/28/2022Radiology
Alivecor, Inc.Alivecor QT Service4/26/2022Cardiovascular
CardiocalmCER-S4/25/2022Cardiovascular
VideaHealth, IncVidea Caries Assist4/21/2022Radiology
Siemens Healthcare GmbHAI-Rad Companion Brain MR4/15/2022Radiology
Fitbit IncDeepvessel Ffr4/8/2022Cardiovascular
Ever Fortune.Ai Co., Ltd.EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System4/4/2022Radiology
Keyamed Na Inc.Deepvessel Ffr4/1/2022Cardiovascular
3D-Side SACustomize3/16/2022Radiology
Arterys Inc.Arterys MICA3/14/2022Radiology
Blue Belt Technologies, Inc.RI.Hip Modeler3/11/2022Radiology
Barco NvDemetra Dermatoscope BDEM-013/11/2022General & Plastic Surgery
Pearl Inc.Second Opinion3/4/2022Radiology
Fresenius Kabi AGVigilant Software Suite – Vigilant Master Med3/1/2022General Hospital
GleamerBoneview3/1/2022Radiology
Zyter, Inc.Zyter RPM2/11/2022Cardiovascular
iSchemaView Inc.Rapid2/8/2022Radiology
Oxos Medical, Inc.Micro C Medical Imaging System, M012/4/2022Radiology
Heuron Co., Ltd.Veuron-Brain-Pab22/4/2022Radiology
Mim Software, Inc.Contour ProtegeAI2/3/2022Radiology
Caption HealthCaption Interpretation Automated Ejection Fraction Software1/19/2022Radiology
Cycle ClarityFollicle Clarity1/19/2022Radiology
Philips Medical Systems Nederland, B.V.Precise Image1/14/2022Radiology
Carestream Health, IncEclipse Ii With Smart Noise Cancellation1/14/2022Radiology
Capsule Surveillance Technologies, SAS /Capsule Tech, Inc.Capsule Surveillance System1/14/2022Cardiovascular
Medicrea International, Inc.Unid Spine Analyzer1/12/2022Radiology
Tomtec Imaging Systems GmbHTomtec-Arena1/6/2022Radiology
MRIguidance B.VBoneMRI12/22/2021Radiology
Claritas Healthtech Pte LtdClaritas Ipet12/22/2021Radiology
Taihao Medical Inc.BU-CAD12/21/2021Radiology
Qure.Ai TechnologiesqXR-BT12/21/2021Radiology
Ultromics Ltd.Echogo Core (2.0)12/20/2021Radiology
Koios Medical, Inc.Koios DS12/16/2021Radiology
Vysioneer Inc.Vbrain12/16/2021Radiology
Archform, IncArchform Orthodontic Software System12/16/2021Dental
Medmind Technology Co., Ltd.Rt-Mind-AI12/15/2021Radiology
Dia Imaging Analysis LtdLVivo Seamless V2.012/9/2021Radiology
Prodigident, Inc.Implastation12/3/2021Radiology
Austrian Institute Of Technology GmbHEncevis12/2/2021Neurology
TherapixelMammoscreen 2.011/26/2021Radiology
Metame Health, Inc.Regulora11/24/2021Gastroenterology/Urology
Phantomics Inc.Myomics Q11/23/2021Radiology
Directed Systems LtdHypotension Decision Assist Model Hda-Or211/23/2021Cardiovascular
Cortechs Labs, Inc.ONQ Neuro11/19/2021Radiology
Chengdu Wision Medical Device Co., Ltd.EndoScreener11/19/2021Gastroenterology/Urology
Lunit Inc.Lunit Insight Mmg11/17/2021Radiology
Intellijoint Surgical Inc.Intellijoint View11/12/2021Radiology
Segana, Inc.RTapp11/10/2021Radiology
Hura Imaging, Inc.Hura CTP v1.011/8/2021Radiology
Ge Medical Systems, LLCCritical Care Suite With Endotracheal Tube Positing Ai Algorithm10/29/2021Radiology
Monarch Medical Technologies, LLCEndoTool SubQ 2.110/28/2021General Hospital
Elekta Solutions AbAdvanced Algorithms For Treatment Management Applications (Aatma)10/25/2021Radiology
Apple Inc.IRNF App10/22/2021Cardiovascular
Mim Software, Inc.Contour ProtegeAI10/20/2021Radiology
Claritas Healthtech Pte LtdiRAD10/20/2021Radiology
Airs Medical Inc.SwiftMR10/14/2021Radiology
Vysioneer Inc.Vbrain-Oar10/12/2021Radiology
Brius Technologies IncBrius Planner Software10/1/2021Dental
Siemens Medical Solutions USA, IncNaeotom Alpha, Scan&Go9/30/2021Radiology
Visus Health It GmbHJiveX (Model Number / Release: 5.3)9/23/2021Radiology
Paige.AIPaige Prostate9/21/2021Pathology
Claripi IncClariSIGMAM9/10/2021Radiology
Arteryflow Technology Co., Ltd.AccuFFRangio9/10/2021Radiology
Ever Fortune.Ai Co., Ltd.EFAI PACS Picture Archiving and Communication System9/10/2021Radiology
Feops NVFEops HEARTguide9/8/2021Cardiovascular
Welldoc, Inc.BlueStar Rx9/8/2021Clinical Chemistry
Amcad Biomed CorporationAmCAD-UT9/8/2021Radiology
Adas3D Medical S.LADAS 3D9/3/2021Radiology
Samsung Electronics Co.,Ltd.Auto Lung Nodule Detection8/31/2021Radiology
Ablacon, Inc.Ablamap Software8/31/2021Cardiovascular
Radiobotics ApsRbknee8/27/2021Radiology
Medtronic NeuromodulationSureTune4 Software8/23/2021Neurology
Cascination AgOtoplan8/20/2021Ear Nose & Throat
Olea MedicalBreastscape V1.08/2/2021Radiology
Qure.Ai TechnologiesqER-Quant7/30/2021Radiology
Eko.Ai Pte. Ltd. D/B/A Us2.AiUs2.V17/27/2021Radiology
Imagen Technologies, IncChest-CAD07/20/2021Radiology
Change Healthcare Canada CompanyChange Healthcare Anatomical Ai7/20/2021Radiology
Icad Inc.Powerlook Density Assessment Software V4.07/12/2021Radiology
Lazarus, 3D, IncPre-Sure7/8/2021Radiology
Natural Cycles Nordic ABNatural Cycles6/24/2021Obstetrics/Gynecology
Dental Wings GmbHCodiagnostix6/21/2021Dental
Medtronic, Inc.LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System6/11/2021Cardiovascular
Digital Diagnostics IncIDx-DR6/10/2021Ophthalmic
Siemens Medical Solutions USA, IncSyngo.Via Mi Workflows, Scenium, Syngo Mbf6/10/2021Radiology
Voluntis, S.A.Insulia Diabetes Management Companion6/4/2021General Hospital
Screenpoint Medical B.V.Transpara 1.7.06/2/2021Radiology
Overject Inc.Overjet Dental Assist5/19/2021Radiology
Medo Dx Pte. Ltd.MEDO-Thyroid4/23/2021Radiology
Genesis Software InnovationsPreview Shoulder4/21/2021Radiology
Quantitative Radiology Solutions, LLCAutomatic Anatomy Recognition (AAR)4/20/2021Radiology
DeepLook Inc.DeepLook PRECISE04/09/2021Radiology
Deepvoxel, Inc.DV.Target4/2/2021Radiology
Siemens Healthcare GmbHsyngo.CT Lung CAD (Version VD20)3/31/2021Radiology
Oxehealth LimitedOxehealth Vital Signs3/26/2021Cardiovascular
Vysioneer Inc.Vbrain3/19/2021Radiology
Icad Inc.Profound AI Software V3.03/12/2021Radiology
Imbio, LLCImbio RV/LV Software3/9/2021Radiology
Optellum LtdOptellum Virtual Nodule Clinic, Optellum Software, Optellum Platform3/5/2021Radiology
Fifth Eye Inc.Analytic For Hemodynamic Instability (Ahi)3/1/2021Cardiovascular
Subtle Medical Inc.SubtleMR2/26/2021Radiology
Cuptimize, Inc.Cuptimize2/26/2021Radiology
Circle Cardiovascular Imaging IncTruplan2/19/2021Radiology
Biowink GmbHClue Birth Control2/18/2021Obstetrics/Gynecology
Dia Imaging Analysis LtdLVivo Software Application2/5/2021Radiology
Visage Imaging GmbHVisage Breast Density1/29/2021Radiology
Heuron Co., Ltd.Veuron-Brain-Pab1/15/2021Radiology
TherapanaceaArt-Plan1/14/2021Radiology
Heartflow, Inc.Heartflow Analysis1/8/2021Cardiovascular
ImPACT Applications, Inc.ImPACT Version 412/25/2020Neurology
Choice Biotech Inc.Planimax Orthodontic Software12/22/2020Dental
Ultromics Ltd.EchoGo Pro12/18/2020Radiology
Resonance Health Analysis Services Pty LtdHepaFat-AI12/7/2020Radiology
Etiometry, Inc.T3 Platform software11/25/2020Cardiovascular
Hologic, Inc.Genius Ai Detection11/18/2020Radiology
Coroventis Research AbCoroflow Cardiovascular System11/13/2020Cardiovascular
Alivecor, Inc.KardiaAI11/12/2020Cardiovascular
Siemens Medical Solutions USA, IncAI-Rad Companion Organs Rt11/6/2020Radiology
Boxview, LLCSmart Alarm Interface10/30/2020Cardiovascular
Radformation, Inc.Autocontour10/30/2020Radiology
Whiterabbit.Ai Inc.WRDensity by Whiterabbit.ai10/30/2020Radiology
Taiwan Aulisa Medical Devices Technologies, Inc.Aulisa Multiple Patient Digital Vital Sign Monitoring System10/30/2020Cardiovascular
M3Dicine Pty Ltd.Stethee Pro 1, Stethee Pro Software System10/9/2020Cardiovascular
Dia Imaging Analysis LtdLVivo Seamless9/29/2020Radiology
Respironics, Inc.Ventilator, Non-Continuous (Respirator)9/25/2020Anesthesiology
LivmorHalo AF Detection System9/23/2020Cardiovascular
Caption HealthCaption Guidance9/18/2020Radiology
Fitbit, Inc.Fitbit ECG App09/11/2020Cardiovascular
3Shape Medical A/S3Shape Implant Studio9/9/2020Radiology
CardiocalmCER-S8/26/2020Cardiovascular
Limbus Ai Inc.Limbus Contour8/13/2020Radiology
Monarch Medical Technologies, LLCEndoTool IV System8/7/2020General Hospital
Samsung Electronics Co., LtdECG Monitor App8/4/2020Cardiovascular
Eyenuk, IncEyeArt8/3/2020Ophthalmic
Siemens Medical Solutions USA, IncAI-Rad Companion Prostate MR7/30/2020Radiology
Imagen Technologies, Inc.Fracturedetect (Fx)7/30/2020Radiology
Caption HealthCaption Interpretation Automated Ejection Fraction Software7/22/2020Radiology
Diorco Co., Ltd.Autolign7/21/2020Dental
Surgical Theater, Inc.SuRgical Planner (SRP) BrainStorm07/17/2020Radiology
Ezra Ai, Inc.Ezra Plexo Software7/10/2020Radiology
iSchemaView Inc.Rapid LVO7/9/2020Radiology
Beijing Infervision Technology Co.,Ltd.Inferread Lung CT.AI7/2/2020Radiology
Mim Software, Inc.Contour ProtegeAI7/2/2020Radiology
iSchemaView Inc.Rapid Aspects6/26/2020Radiology
AVICENNA.AICINA06/24/2020Radiology
Dia Imaging Analysis LtdLvivo Software Application6/23/2020Radiology
Ulab Systems, Inc.Ulab Systems Udesign Software6/23/2020Dental
Akili Interactive Labs Inc.EndeavorRx6/15/2020Neurology
Quantib BVQuantib AI Node6/15/2020Radiology
Shanghai United Imaging Healthcare Co., Ltd.uWS-MI6/11/2020Radiology
Medo.AiMEDO ARIA6/11/2020Radiology
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