AI Device Tracker / Cardiology
FDA-authorised AI devices in cardiology
154 AI-enabled devices with cardiology as the lead FDA review panel, newest first. First in this list: 2008; most recent: 2026-06-08.
| Decision date | Device | Company | FDA record |
|---|---|---|---|
| 2026-06-08 | EchoNext | Pathwai, Inc. | K260332 · 510(k) |
| 2026-05-29 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | K252859 · 510(k) |
| 2026-05-22 | PCWP Analysis Software | Cardiosense, Inc. | DEN250057 · De Novo |
| 2026-04-17 | Novasight Hybrid System | Conavi Medical, Inc. | K252945 · 510(k) |
| 2026-04-07 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | Anumana, Inc. | K253801 · 510(k) |
| 2026-03-28 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. | K252360 · 510(k) |
| 2026-03-12 | Tyto Stethoscope (G3) | Tyto Care , Ltd. | K252089 · 510(k) |
| 2026-02-20 | CARTO 3 EP Navigation System V8.4 | Biosense Webster, Inc. | K252972 · 510(k) |
| 2026-02-13 | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | K250233 · 510(k) |
| 2026-02-06 | Kneevoice Cartilage Evaluation System (750-3600-001) | Kneevoice, Inc. | K252076 · 510(k) |
| 2026-02-06 | SafeBeat Rx App | SafeBeat Rx, Inc. | K251218 · 510(k) |
| 2026-02-02 | Vital Signs | Oxehealth Limited | K251200 · 510(k) |
| 2026-01-23 | BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | K243349 · 510(k) |
| 2026-01-22 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | K252984 · 510(k) |
| 2026-01-09 | Corvair Monza | AliveCor, Inc. | K252589 · 510(k) |
| 2025-12-19 | eMurmur Heart AI | Csd Labs | K252284 · 510(k) |
| 2025-12-18 | Assert-IQ (DM5100) | Abbott Medical | K253516 · 510(k) |
| 2025-12-16 | prolaio eVO2peak Module (Version 1.0) | Prolaio, Inc. | K252204 · 510(k) |
| 2025-12-11 | DeepRhythmAI | Medicalgorithmics S.A. | K253141 · 510(k) |
| 2025-11-25 | FEops HEARTguide Simulation Application | Feops NV | K250635 · 510(k) |
| 2025-11-21 | CardioVision | Icardio.Ai | K251293 · 510(k) |
| 2025-10-28 | Aurora EV ICD (DVEA3E4) | Medtronic, Inc. | P220012/S059 · PMA |
| 2025-10-28 | Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I | Medtronic Cardiac Rhythm Disease Management | P980016/S939 · PMA |
| 2025-09-19 | Bunkerhill ECG-EF | BunkerHill Health | K250649 · 510(k) |
| 2025-09-17 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott | K251221 · 510(k) |
| 2025-09-12 | Volta AF-Xplorer II | Volta Medical | K251518 · 510(k) |
| 2025-09-12 | Stethophone Pro | Sparrow Acoustics, Inc. | K252595 · 510(k) |
| 2025-09-11 | Hypertension Notification Feature (HTNF) | Apple Inc. | K250507 · 510(k) |
| 2025-08-27 | Vital Signs | Oxehealth Limited | K243687 · 510(k) |
| 2025-08-12 | Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. | K251494 · 510(k) |
| 2025-08-06 | Cardiologs Holter Platform | Philips France Commercial | K250569 · 510(k) |
| 2025-07-28 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | K250652 · 510(k) |
| 2025-07-18 | HeartFlow Analysis | HeartFlow, Inc. | K250902 · 510(k) |
| 2025-07-15 | Tempus ECG-Low EF | Tempus AI, Inc. | K250119 · 510(k) |
| 2025-06-20 | Us2.ca | Eko.Ai Pte Ltd. D/B/A Us2.Ai | K250151 · 510(k) |
| 2025-06-15 | Withings ECG App | Withings | K240795 · 510(k) |
| 2025-06-06 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.R.L. | K242737 · 510(k) |
| 2025-06-04 | PhysCade System | PhysCade, Inc. | K250749 · 510(k) |
| 2025-05-27 | DeepRhythmAI | Medicalgorithmics S.A. | K250932 · 510(k) |
| 2025-05-21 | InVision Precision Cardiac Amyloid | InVision Medical Technology Corporation | K243866 · 510(k) |
| 2025-05-09 | Volta AF-Xplorer | Volta Medical | K243812 · 510(k) |
| 2025-05-02 | AT-Patch (ATP-C130/ATP-C70) | ATsens Co.,Ltd. | K242583 · 510(k) |
| 2025-04-30 | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati | Element Science, Inc. | P230022 · PMA |
| 2025-04-17 | VitalRhythm | VitalConnect, Inc. | K242129 · 510(k) |
| 2025-02-25 | Loss of Pulse Detection | Fitbit | K242967 · 510(k) |
| 2024-12-04 | DeepRhythmAI | Medicalgorithmics S.A. | K241197 · 510(k) |
| 2024-11-18 | Informed Vital Core Application (IVC App) | Mindset Medical, Inc. | K241633 · 510(k) |
| 2024-11-15 | EchoGo Amyloidosis (1.0) | Ultromics Limited | K240860 · 510(k) |
| 2024-09-23 | EchoGo Heart Failure (2.0) | Ultromics Limited | K240013 · 510(k) |
| 2024-08-16 | HeartKey® Rhythm | B-Secur Limited | K233755 · 510(k) |
| 2024-08-02 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences, LLC | K233984 · 510(k) |
| 2024-06-21 | eCARTv5 Clinical Deterioration Suite (eCART) | AgileMD, Inc. | K233253 · 510(k) |
| 2024-06-21 | Tempus ECG-AF | Tempus AI, Inc. | K233549 · 510(k) |
| 2024-06-07 | Impala | AliveCor, Inc. | K232035 · 510(k) |
| 2024-06-07 | Corvair | AliveCor, Inc. | K231010 · 510(k) |
| 2024-05-07 | ASSURE Wearable ECG | Kestra Medical Technologies, Inc. | K233864 · 510(k) |
| 2024-04-05 | CorVista System with PH Add-On | Analytics for Life, Inc. | K233666 · 510(k) |
| 2024-04-05 | APPRAISE-HRI | The Surgeon General, Department of the Army (TSG-DA) | K233249 · 510(k) |
| 2024-03-28 | Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. | K233409 · 510(k) |
| 2024-01-13 | CLEWICU System | Clew Medical Ltd. | K233216 · 510(k) |
| 2023-12-06 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | K233562 · 510(k) |
| 2023-10-25 | SignalHF (IM008) | Implicity Inc. | K230842 · 510(k) |
| 2023-10-06 | Vivio® LVEDP System | Avicena, LLC | K223905 · 510(k) |
| 2023-09-28 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | K232699 · 510(k) |
| 2023-09-27 | Volta AF-Xplorer | Volta Medical | K232616 · 510(k) |
| 2023-09-08 | Cleerly ISCHEMIA | Cleerly, Inc | K231335 · 510(k) |
| 2023-09-08 | CorVista® System | CorVista Health, Inc. | K232686 · 510(k) |
| 2023-09-07 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | Biosense Webster, Inc. | K231207 · 510(k) |
| 2023-09-01 | FaceHeart Vitals Software Development Kit (FH vitals SDK) | FaceHeart Corp. | K223622 · 510(k) |
| 2023-08-23 | Withings Scan Monitor 2.0 | Withings | K230812 · 510(k) |
| 2023-08-03 | Viz HCM | Viz.ai, Inc. | DEN230003 · De Novo |
| 2023-07-26 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | K231038 · 510(k) |
| 2023-07-21 | Irregular Rhythm Notification Feature (IRNF) | Apple Inc. | K231173 · 510(k) |
| 2023-07-12 | AusculThing ACC | AusculThing Oy | K230823 · 510(k) |
| 2023-05-25 | Saranas Early Bird Bleed Monitoring System | Saranas Inc. | K230273 · 510(k) |
| 2023-05-02 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd | K230292 · 510(k) |
| 2023-04-26 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | Medtronic, Inc. | K230553 · 510(k) |
| 2023-04-05 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | Medtronic, Inc. | K223630 · 510(k) |
| 2023-03-17 | Alio | Alio, Inc. | K223073 · 510(k) |
| 2023-02-15 | ZEUS System | iRhythm Technologies, Inc. | K222389 · 510(k) |
| 2023-01-21 | VX1+ | Volta Medical | K223516 · 510(k) |
| 2022-12-01 | STAR Apollo Mapping System | Rhythm Al, Ltd | K220786 · 510(k) |
| 2022-10-31 | Avive Automated External Defibrillator (AED) System | Avive Solutions, Inc. | P210015 · PMA |
| 2022-10-14 | HeartFlow Analysis | HeartFlow, Inc. | K213857 · 510(k) |
| 2022-08-25 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | K221962 · 510(k) |
| 2022-07-27 | DeepRhythmAI | Medicalgorithmics S.A. | K210822 · 510(k) |
| 2022-07-19 | ZEUS System (Zio Watch) | iRhythm Technologies, Inc. | K213409 · 510(k) |
| 2022-07-19 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor | Verily Life Sciences LLC | K213357 · 510(k) |
| 2022-07-14 | AHI System | Fifth Eye Inc. | K221203 · 510(k) |
| 2022-06-29 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | K213794 · 510(k) |
| 2022-06-03 | Atrial Fibrillation History Feature | Apple Inc. | K213971 · 510(k) |
| 2022-05-31 | eMurmur Heart AI | CSD Labs GmbH | K220766 · 510(k) |
| 2022-04-29 | Oxehealth Vital Signs | Oxehealth Limited | K220899 · 510(k) |
| 2022-04-26 | AliveCor QT Service | AliveCor, Inc. | K212662 · 510(k) |
| 2022-04-01 | DEEPVESSEL FFR | KeyaMed NA Inc. | K213657 · 510(k) |
| 2021-12-03 | AHI System | Fifth Eye Inc. | K212219 · 510(k) |
| 2021-11-03 | IM007 | Implicity, Inc. | K210543 · 510(k) |
| 2021-10-22 | IRNF App | Apple Inc. | K212516 · 510(k) |
| 2021-07-20 | Vital Signs | Oxehealth Limited | K211906 · 510(k) |
| 2021-06-11 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | K210484 · 510(k) |
| 2021-05-21 | Zio ECG Utilization Software (ZEUS) System | iRhythm Technologies, Inc. | K202527 · 510(k) |
| 2021-04-01 | Gili Pro BioSensor (also known as Gili BioSensor System) | ContinUse Biometrics Ltd. | DEN200038 · De Novo |
| 2021-03-26 | Oxehealth Vital Signs | Oxehealth Limited | DEN200019 · De Novo |
| 2021-03-01 | Analytic for Hemodynamic Instability (AHI) | Fifth Eye Inc. | DEN200022 · De Novo |
| 2021-01-09 | CLEWICU System (ClewICUServer and ClewICUnitor) | CLEW Medical Ltd. | K200717 · 510(k) |
| 2021-01-08 | HeartFlow Analysis | HeartFlow, Inc. | K203329 · 510(k) |
| 2020-11-12 | KardiaAI | AliveCor, Inc. | K201985 · 510(k) |
| 2020-10-09 | Stethee Pro 1, Stethee Pro Software System | M3DICINE Pty Ltd. | K193631 · 510(k) |
| 2020-09-16 | VX1 | Volta Medical | K201298 · 510(k) |
| 2020-09-02 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant Inc. | K200833 · 510(k) |
| 2020-03-26 | BodyGuardian Remote Monitoring System | Preventice Technologies, Inc. | K192732 · 510(k) |
| 2020-03-20 | AI-ECG Tracker | Shenzhen Carewell Electronics Co., Ltd. | K200036 · 510(k) |
| 2020-01-17 | Study Watch with Irregular Pulse Monitor | Verily Life Sciences LLC | K192415 · 510(k) |
| 2020-01-15 | Eko Analysis Software | Eko Devices Inc | K192004 · 510(k) |
| 2019-12-09 | FFRangio | CathWorks Ltd | K192442 · 510(k) |
| 2019-11-25 | SOZO | ImpediMed Limited | K190529 · 510(k) |
| 2019-11-01 | MIMOSA Imager | MIMOSA Diagnostics Inc | K190334 · 510(k) |
| 2019-09-11 | PeraMobile and PeraWatch | PeraHealth, Inc. | K183370 · 510(k) |
| 2019-08-23 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | K190593 · 510(k) |
| 2019-08-15 | HeartFlow FFRct Analysis | HeartFlow, Inc. | K190925 · 510(k) |
| 2019-08-15 | Biovitals Analytics Engine | Biofourmis Singapore Pte. Ltd | K183282 · 510(k) |
| 2019-07-10 | physIQ Heart Rhythm and Respiratory Module | physIQ, Inc | K183322 · 510(k) |
| 2019-05-21 | Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure | Edwards Lifeciences, LLC | K183646 · 510(k) |
| 2019-04-17 | eMurmur ID | CSD Labs GmbH | K181988 · 510(k) |
| 2019-03-29 | Loop System | Spry Health, Inc. | K181352 · 510(k) |
| 2019-03-11 | KardiaAI | AliveCor, Inc. | K181823 · 510(k) |
| 2019-03-07 | RhythmAnalytics | Biofourmis Singapore Pte. Ltd. | K182344 · 510(k) |
| 2019-02-16 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant Inc. | K183704 · 510(k) |
| 2019-01-17 | Study Watch | Verily Life Sciences LLC | K182456 · 510(k) |
| 2018-12-19 | FFRangio System | CathWorks Ltd | K182149 · 510(k) |
| 2018-12-14 | Cardio-TriTest v6.5 | Cardio-Phoenix Inc. | K182790 · 510(k) |
| 2018-12-06 | FFRct | HeartFlow, Inc | K182035 · 510(k) |
| 2018-11-19 | AI-ECG Platform | Shenzhen Carewell Electronics., Ltd | K180432 · 510(k) |
| 2018-09-28 | FibriCheck | Qompium nv | K173872 · 510(k) |
| 2018-08-29 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. | K181502 · 510(k) |
| 2018-05-01 | PeraServer and PeraTrend | PeraHealth, Inc. | K172959 · 510(k) |
| 2018-04-16 | SOZO | ImpediMed Limited | K180126 · 510(k) |
| 2018-03-16 | Acumen Hypotension Prediction Index (HPI) Feature Software | Edwards Lifesciences LLC | DEN160044 · De Novo |
| 2018-01-04 | WAVE Clinical Platform | Excel Medical Electronics, LLC | K171056 · 510(k) |
| 2017-12-22 | SOZO | ImpediMed Limited | K172507 · 510(k) |
| 2017-11-07 | Rooti Rx ECG Event Recorder, Rooti Link APP Software | Rooti Labs Ltd. | K163694 · 510(k) |
| 2017-09-27 | Peerbridge Cor(TM) System | Peerbridge Health INc. | K171936 · 510(k) |
| 2017-08-17 | SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 | SPECTRALMD, INC. | K163339 · 510(k) |
| 2017-08-11 | SOZO | ImpediMed Limited | K172122 · 510(k) |
| 2017-06-26 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | K170568 · 510(k) |
| 2017-02-23 | Reveal LINQ | Medtronic, Inc. | K162855 · 510(k) |
| 2016-10-19 | Tyto Stethoscope | Tyto Care Ltd. | K160401 · 510(k) |
| 2016-08-24 | FFRct | HEARTFLOW, INC. | K161772 · 510(k) |
| 2016-07-15 | Steth IO | STRATOSCIENTIFIC, INC. | K160016 · 510(k) |
| 2016-01-13 | FFRct | HEARTFLOW, INC. | K152733 · 510(k) |
| 2015-06-11 | Personalized Physiology Analytics Engine software | VGBio, Inc (DBA PhysIQ) | K142512 · 510(k) |
| 2013-09-04 | SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION | DIACOUSTIC MEDICAL DEVICES (PTY) LTD. | K131044 · 510(k) |
| 2012-07-27 | SENSICARDIAC | DIACOUSTIC MEDICAL (PTY) | K121617 · 510(k) |
| 2008-07-17 | VISENSIA | OBS MEDICAL | K081140 · 510(k) |
How to read this list
- 510(k) clearance means the FDA found the device substantially equivalent to one already on the market. Most AI devices reach the market this way.
- De Novo is used for new, low-to-moderate risk device types with no existing equivalent; it creates a new device category.
- PMA approval is the strictest route, for higher-risk devices.
- Authorisation means the device may be sold in the US for its stated use. It does not prove that the device improves patient outcomes, and it does not mean your hospital uses it.
- This list covers US FDA decisions only. Approval in the EU (CE marking) or the UK (UKCA) is a separate process.
Source: FDA Artificial Intelligence-Enabled Medical Devices list, downloaded 2026-11-05. Information only, not a recommendation of any device.