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154 devices · 100 companies · 2008 to 2026

AI-enabled cardiovascular devices on FDA's list

154 devices in the Cardiovascular panel, 2008 to 2026, from 100 companies across 49 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (145 of 154 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes in the Cardiovascular panel

By year in the Cardiovascular panel

Companies with more than one device here

The newest 150 devices

154 devices in the Cardiovascular panel is more than one table should carry. The 150 newest decisions are below; every device has a page of its own, reached through the product-code and year lists above.

Cardiovascular · newest 150 of 154 devices
DecisionDeviceCompanyProduct codeFDA
EchoNextK260332 · 510(k)Pathwai, Inc.QXOdatabase entry
ZEUS PlatformK252859 · 510(k)iRhythm Technologies, Inc.DQKdatabase entry
PCWP Analysis SoftwareDEN250057 · De NovoCardiosense, Inc.SIFdatabase entry
Novasight Hybrid SystemK252945 · 510(k)Conavi Medical, Inc.OBJdatabase entry
ECG-AI Cardiac AmyloidosisK253801 · 510(k)Anumana, Inc.SHPdatabase entry
ECG-AI Pulmonary HypertensionK252360 · 510(k)Anumana, Inc.SATdatabase entry
Tyto StethoscopeK252089 · 510(k)Tyto Care , Ltd.DQDdatabase entry
CARTO 3 EP Navigation System V8.4K252972 · 510(k)Biosense Webster, Inc.DQKdatabase entry
PreemptiveAI Clinical SDKK250233 · 510(k)Measure Labs, Inc. (Dba Preemptiveai, Inc.)DXHdatabase entry
Kneevoice Cartilage Evaluation SystemK252076 · 510(k)Kneevoice, Inc.DQDdatabase entry
SafeBeat Rx AppK251218 · 510(k)SafeBeat Rx, Inc.DQKdatabase entry
Vital SignsK251200 · 510(k)Oxehealth LimitedQMEdatabase entry
BodyGuardian Remote Monitoring SystemK243349 · 510(k)Boston Scientific Cardiac Diagnostic Technologies, Inc.DSIdatabase entry
Perin Health SystemK252984 · 510(k)Perin Health Devices, LLCDRGdatabase entry
Corvair MonzaK252589 · 510(k)AliveCor, Inc.MHXdatabase entry
eMurmur Heart AIK252284 · 510(k)Csd LabsDQDdatabase entry
Assert-IQK253516 · 510(k)Abbott MedicalMXDdatabase entry
prolaio eVO2peak ModuleK252204 · 510(k)Prolaio, Inc.PPWdatabase entry
DeepRhythmAIK253141 · 510(k)Medicalgorithmics S.A.DQKdatabase entry
FEops HEARTguide Simulation ApplicationK250635 · 510(k)Feops NVQQIdatabase entry
CardioVisionK251293 · 510(k)Icardio.AiQUOdatabase entry
Aurora EV ICDP220012/S059 · PMAMedtronic, Inc.LWSdatabase entry
Cobalt MRI ICDP980016/S939 · PMAMedtronic Cardiac Rhythm Disease ManagementLWSdatabase entry
Bunkerhill ECG-EFK250649 · 510(k)BunkerHill HealthQYEdatabase entry
Assert-IQK251221 · 510(k)AbbottMXDdatabase entry
Volta AF-Xplorer IIK251518 · 510(k)Volta MedicalDQKdatabase entry
Stethophone ProK252595 · 510(k)Sparrow Acoustics, Inc.DQDdatabase entry
Hypertension Notification FeatureK250507 · 510(k)Apple Inc.SFRdatabase entry
Vital SignsK243687 · 510(k)Oxehealth LimitedQMEdatabase entry
Eko Foundation Analysis Software with TransformeK251494 · 510(k)Eko Health, Inc.DQDdatabase entry
Cardiologs Holter PlatformK250569 · 510(k)Philips France CommercialDPSdatabase entry
ECG-AI Low Ejection FractionK250652 · 510(k)Anumana, Inc.QYEdatabase entry
HeartFlow AnalysisK250902 · 510(k)HeartFlow, Inc.PJAdatabase entry
Tempus ECG-Low EFK250119 · 510(k)Tempus AI, Inc.QYEdatabase entry
Us2.caK250151 · 510(k)Eko.Ai Pte Ltd. D/B/A Us2.AiSDJdatabase entry
Withings ECG AppK240795 · 510(k)WithingsQDAdatabase entry
Empatica Health Monitoring PlatformK242737 · 510(k)Empatica S.R.L.MWIdatabase entry
PhysCade SystemK250749 · 510(k)PhysCade, Inc.DQKdatabase entry
DeepRhythmAIK250932 · 510(k)Medicalgorithmics S.A.DQKdatabase entry
InVision Precision Cardiac AmyloidK243866 · 510(k)InVision Medical Technology CorporationSDJdatabase entry
Volta AF-XplorerK243812 · 510(k)Volta MedicalDQKdatabase entry
AT-PatchK242583 · 510(k)ATsens Co.,Ltd.DSHdatabase entry
Jewel Patch Wearable Cardioverter DefibrillatorP230022 · PMAElement Science, Inc.MVKdatabase entry
VitalRhythmK242129 · 510(k)VitalConnect, Inc.DQKdatabase entry
Loss of Pulse DetectionK242967 · 510(k)FitbitSDYdatabase entry
DeepRhythmAIK241197 · 510(k)Medicalgorithmics S.A.DQKdatabase entry
Informed Vital Core ApplicationK241633 · 510(k)Mindset Medical, Inc.QMEdatabase entry
EchoGo AmyloidosisK240860 · 510(k)Ultromics LimitedSDJdatabase entry
EchoGo Heart FailureK240013 · 510(k)Ultromics LimitedQUOdatabase entry
HeartKey RhythmK233755 · 510(k)B-Secur LimitedDQKdatabase entry
Acumen Assisted Fluid ManagementK233984 · 510(k)Edwards Lifesciences, LLCQMSdatabase entry
eCARTv5 Clinical Deterioration SuiteK233253 · 510(k)AgileMD, Inc.QNLdatabase entry
Tempus ECG-AFK233549 · 510(k)Tempus AI, Inc.SBQdatabase entry
ImpalaK232035 · 510(k)AliveCor, Inc.DPSdatabase entry
CorvairK231010 · 510(k)AliveCor, Inc.MHXdatabase entry
ASSURE Wearable ECGK233864 · 510(k)Kestra Medical Technologies, Inc.MWJdatabase entry
CorVista System with PH Add-OnK233666 · 510(k)Analytics for Life, Inc.SATdatabase entry
APPRAISE-HRIK233249 · 510(k)The Surgeon General, Department of the Army (TSG-DA)SARdatabase entry
Eko Low Ejection Fraction ToolK233409 · 510(k)Eko Health, Inc.QYEdatabase entry
CLEWICU SystemK233216 · 510(k)Clew Medical Ltd.QNLdatabase entry
LINQ II Insertable Cardiac MonitorK233562 · 510(k)Medtronic, Inc.MXDdatabase entry
SignalHFK230842 · 510(k)Implicity Inc.QNLdatabase entry
Vivio LVEDP SystemK223905 · 510(k)Avicena, LLCQUOdatabase entry
Low Ejection Fraction AI-ECG AlgorithmK232699 · 510(k)Anumana, Inc.QYEdatabase entry
Volta AF-XplorerK232616 · 510(k)Volta MedicalDQKdatabase entry
Cleerly ISCHEMIAK231335 · 510(k)Cleerly, IncQXZdatabase entry
CorVista SystemK232686 · 510(k)CorVista Health, Inc.QXXdatabase entry
CARTO 3 EP Navigation System Software V8.0K231207 · 510(k)Biosense Webster, Inc.DQKdatabase entry
FaceHeart Vitals Software Development KitK223622 · 510(k)FaceHeart Corp.QMEdatabase entry
Withings Scan Monitor 2.0K230812 · 510(k)WithingsDPSdatabase entry
Viz HCMDEN230003 · De NovoViz.ai, Inc.QXOdatabase entry
Global Hypoperfusion IndexK231038 · 510(k)Edwards Lifesciences, LLCQNLdatabase entry
Irregular Rhythm Notification FeatureK231173 · 510(k)Apple Inc.QDBdatabase entry
AusculThing ACCK230823 · 510(k)AusculThing OyDQDdatabase entry
Saranas Early Bird Bleed Monitoring SystemK230273 · 510(k)Saranas Inc.QFJdatabase entry
Samsung ECG Monitor Application with Irregular HK230292 · 510(k)Samsung Electronics Co., LtdQDAdatabase entry
LINQ II Insertable Cardiac Monitor, CareLink SmaK230553 · 510(k)Medtronic, Inc.MXDdatabase entry
Reveal LINQ Insertable Cardiac Monitor, LINQ IIK223630 · 510(k)Medtronic, Inc.MXDdatabase entry
AlioK223073 · 510(k)Alio, Inc.DRGdatabase entry
ZEUS SystemK222389 · 510(k)iRhythm Technologies, Inc.DQKdatabase entry
VX1+K223516 · 510(k)Volta MedicalDQKdatabase entry
STAR Apollo Mapping SystemK220786 · 510(k)Rhythm Al, LtdDQKdatabase entry
Avive Automated External DefibrillatorP210015 · PMAAvive Solutions, Inc.MKJdatabase entry
HeartFlow AnalysisK213857 · 510(k)HeartFlow, Inc.PJAdatabase entry
LINQ II Insertable Cardiac MonitorK221962 · 510(k)Medtronic, Inc.MXDdatabase entry
DeepRhythmAIK210822 · 510(k)Medicalgorithmics S.A.DQKdatabase entry
ZEUS SystemK213409 · 510(k)iRhythm Technologies, Inc.DQKdatabase entry
Study Watch with Irregular Pulse MonitorK213357 · 510(k)Verily Life Sciences LLCDXHdatabase entry
AHI SystemK221203 · 510(k)Fifth Eye Inc.QNVdatabase entry
Eko Murmur Analysis SoftwareK213794 · 510(k)Eko Devices, Inc.DQDdatabase entry
Atrial Fibrillation History FeatureK213971 · 510(k)Apple Inc.QDBdatabase entry
eMurmur Heart AIK220766 · 510(k)CSD Labs GmbHDQDdatabase entry
Oxehealth Vital SignsK220899 · 510(k)Oxehealth LimitedQMEdatabase entry
AliveCor QT ServiceK212662 · 510(k)AliveCor, Inc.DQKdatabase entry
DEEPVESSEL FFRK213657 · 510(k)KeyaMed NA Inc.PJAdatabase entry
AHI SystemK212219 · 510(k)Fifth Eye Inc.QNVdatabase entry
IM007K210543 · 510(k)Implicity, Inc.DQKdatabase entry
IRNF AppK212516 · 510(k)Apple Inc.QDBdatabase entry
Vital SignsK211906 · 510(k)Oxehealth LimitedQMEdatabase entry
LINQ II Insertable Cardiac Monitor, Zelda AI ECGK210484 · 510(k)Medtronic, Inc.MXDdatabase entry
Zio ECG Utilization SoftwareK202527 · 510(k)iRhythm Technologies, Inc.DQKdatabase entry
Gili Pro BioSensorDEN200038 · De NovoContinUse Biometrics Ltd.QOKdatabase entry
Oxehealth Vital SignsDEN200019 · De NovoOxehealth LimitedQMEdatabase entry
Analytic for Hemodynamic InstabilityDEN200022 · De NovoFifth Eye Inc.QNVdatabase entry
CLEWICU SystemK200717 · 510(k)CLEW Medical Ltd.QNLdatabase entry
HeartFlow AnalysisK203329 · 510(k)HeartFlow, Inc.PJAdatabase entry
KardiaAIK201985 · 510(k)AliveCor, Inc.DQKdatabase entry
Stethee Pro 1, Stethee Pro Software SystemK193631 · 510(k)M3DICINE Pty Ltd.DQDdatabase entry
VX1K201298 · 510(k)Volta MedicalDQKdatabase entry
RX-1 Rhythm Express Remote Cardiac Monitoring SyK200833 · 510(k)VivaQuant Inc.MLOdatabase entry
BodyGuardian Remote Monitoring SystemK192732 · 510(k)Preventice Technologies, Inc.DSIdatabase entry
AI-ECG TrackerK200036 · 510(k)Shenzhen Carewell Electronics Co., Ltd.DPSdatabase entry
Study Watch with Irregular Pulse MonitorK192415 · 510(k)Verily Life Sciences LLCDXHdatabase entry
Eko Analysis SoftwareK192004 · 510(k)Eko Devices IncMWIdatabase entry
FFRangioK192442 · 510(k)CathWorks LtdQEKdatabase entry
SOZOK190529 · 510(k)ImpediMed LimitedQJBdatabase entry
MIMOSA ImagerK190334 · 510(k)MIMOSA Diagnostics IncMUDdatabase entry
PeraMobile and PeraWatchK183370 · 510(k)PeraHealth, Inc.MWIdatabase entry
Zio XT ECG Monitoring System, Zio AT ECG MonitorK190593 · 510(k)iRhythm Technologies, Inc.DQKdatabase entry
HeartFlow FFRct AnalysisK190925 · 510(k)HeartFlow, Inc.PJAdatabase entry
Biovitals Analytics EngineK183282 · 510(k)Biofourmis Singapore Pte. LtdPLBdatabase entry
physIQ Heart Rhythm and Respiratory ModuleK183322 · 510(k)physIQ, IncDPSdatabase entry
Acumen Hypotension Prediction Index – EV1000 CliK183646 · 510(k)Edwards Lifeciences, LLCQAQdatabase entry
eMurmur IDK181988 · 510(k)CSD Labs GmbHDQDdatabase entry
Loop SystemK181352 · 510(k)Spry Health, Inc.DQAdatabase entry
KardiaAIK181823 · 510(k)AliveCor, Inc.DQKdatabase entry
RhythmAnalyticsK182344 · 510(k)Biofourmis Singapore Pte. Ltd.DQKdatabase entry
RX-1 Rhythm Express Remote Cardiac Monitoring SyK183704 · 510(k)VivaQuant Inc.DXHdatabase entry
Study WatchK182456 · 510(k)Verily Life Sciences LLCDXHdatabase entry
FFRangio SystemK182149 · 510(k)CathWorks LtdQEKdatabase entry
Cardio-TriTest v6.5K182790 · 510(k)Cardio-Phoenix Inc.DPSdatabase entry
FFRctK182035 · 510(k)HeartFlow, IncPJAdatabase entry
AI-ECG PlatformK180432 · 510(k)Shenzhen Carewell Electronics., LtdDQKdatabase entry
FibriCheckK173872 · 510(k)Qompium nvDXHdatabase entry
Zio AT ECG Monitoring System, ZEUS SystemK181502 · 510(k)iRhythm Technologies, Inc.DQKdatabase entry
PeraServer and PeraTrendK172959 · 510(k)PeraHealth, Inc.MWIdatabase entry
SOZOK180126 · 510(k)ImpediMed LimitedOBHdatabase entry
Acumen Hypotension Prediction IndexDEN160044 · De NovoEdwards Lifesciences LLCQAQdatabase entry
WAVE Clinical PlatformK171056 · 510(k)Excel Medical Electronics, LLCMWIdatabase entry
SOZOK172507 · 510(k)ImpediMed LimitedDSBdatabase entry
Rooti Rx ECG Event Recorder, Rooti Link APP SoftK163694 · 510(k)Rooti Labs Ltd.DRGdatabase entry
Peerbridge CorK171936 · 510(k)Peerbridge Health INc.DSHdatabase entry
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0K163339 · 510(k)SPECTRALMD, INC.DPTdatabase entry
SOZOK172122 · 510(k)ImpediMed LimitedOBHdatabase entry
CardioLogs ECG Analysis PlatformK170568 · 510(k)Cardiologs TechnologiesDPSdatabase entry
Reveal LINQK162855 · 510(k)Medtronic, Inc.MXDdatabase entry
Tyto StethoscopeK160401 · 510(k)Tyto Care Ltd.DQDdatabase entry
FFRctK161772 · 510(k)HEARTFLOW, INC.PJAdatabase entry
Steth IOK160016 · 510(k)STRATOSCIENTIFIC, INC.DQDdatabase entry
FFRctK152733 · 510(k)HEARTFLOW, INC.PJAdatabase entry

Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.

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