FDA-cleared AI devices for cardiovascular 2025
2025 has 30 cardiovascular AI devices, 100% more than 2024 (15). That is 19.5% of the 154 cardiovascular devices on the FDA list, and 9% of all AI-device decisions dated 2025. The most active were Medicalgorithmics S.A. (2), Volta Medical (2), Abbott (1). The newest is eMurmur Heart AI from Csd Labs, decided on December 19, 2025.
Companies in 2025
By month
Product codes
DQKComputer, Diagnostic, Programmable6DQDStethoscope, Electronic3QYEReduced Ejection Fraction Machine Learning-Based Notification Software3LWSCode2MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)2SDJAdjunctive Cardiac Amyloidosis Status Indicator2DPSElectrocardiograph1DSHRecorder, Magnetic Tape, Medical1All 30 devices
- eMurmur Heart AICsd Labs · Cardiovascular
- Assert-IQ (DM5100)Abbott Medical · Cardiovascular
- prolaio eVO2peak Module (Version 1.0)Prolaio, Inc. · Cardiovascular
- DeepRhythmAIMedicalgorithmics S.A. · Cardiovascular
- FEops HEARTguide Simulation ApplicationFeops NV · Cardiovascular
- CardioVisionIcardio.Ai · Cardiovascular
- Aurora EV ICD (DVEA3E4)Medtronic, Inc. · Cardiovascular
- Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI IMedtronic Cardiac Rhythm Disease Management · Cardiovascular
- Bunkerhill ECG-EFBunkerHill Health · Cardiovascular
- Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)Abbott · Cardiovascular
- Volta AF-Xplorer IIVolta Medical · Cardiovascular
- Stethophone ProSparrow Acoustics, Inc. · Cardiovascular
- Hypertension Notification Feature (HTNF)Apple Inc. · Cardiovascular
- Vital SignsOxehealth Limited · Cardiovascular
- Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc. · Cardiovascular
- Cardiologs Holter PlatformPhilips France Commercial · Cardiovascular
- ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc. · Cardiovascular
- HeartFlow AnalysisHeartFlow, Inc. · Cardiovascular
- Tempus ECG-Low EFTempus AI, Inc. · Cardiovascular
- Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai · Cardiovascular
- Withings ECG AppWithings · Cardiovascular
- Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.R.L. · Cardiovascular
- PhysCade SystemPhysCade, Inc. · Cardiovascular
- DeepRhythmAIMedicalgorithmics S.A. · Cardiovascular
- InVision Precision Cardiac AmyloidInVision Medical Technology Corporation · Cardiovascular
- Volta AF-XplorerVolta Medical · Cardiovascular
- AT-Patch (ATP-C130/ATP-C70)ATsens Co.,Ltd. · Cardiovascular
- Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin PreparatiElement Science, Inc. · Cardiovascular
- VitalRhythmVitalConnect, Inc. · Cardiovascular
- Loss of Pulse DetectionFitbit · Cardiovascular
Frequently asked questions
How many FDA-cleared AI cardiovascular devices were there in 2025?
30 AI-enabled cardiovascular devices have a final decision dated 2025, from 28 companies.
How does 2025 compare with 2024 for AI cardiovascular devices?
2025 has 30 cardiovascular AI devices, 100% more than 2024 (15).
Which companies cleared the most AI cardiovascular devices in 2025?
Medicalgorithmics S.A. (2), Volta Medical (2), Abbott (1).
What was the most recent AI cardiovascular device in 2025?
eMurmur Heart AI from Csd Labs (K252284), decided on December 19, 2025. Product code DQD.
Which product codes were most common for AI cardiovascular devices in 2025?
DQK (Computer, Diagnostic, Programmable): 6; DQD (Stethoscope, Electronic): 3; QYE (Reduced Ejection Fraction Machine Learning-Based Notification Software): 3.
Cite as: AI Device Radar, “FDA-cleared AI devices for cardiovascular 2025,” https://ai-device-radar.vercel.app/specialty/cardiovascular/2025 (FDA list through 2026-06-29).