FDA-cleared AI devices for cardiovascular 2026
2026 is still in progress (FDA decisions through June 29, 2026): 15 cardiovascular AI devices so far, against 30 in all of 2025. That is 9.7% of the 154 cardiovascular devices on the FDA list, and 8.3% of all AI-device decisions dated 2026. The most active were Anumana, Inc. (2), AliveCor, Inc. (1), Biosense Webster, Inc. (1). The newest is EchoNext from Pathwai, Inc., decided on June 8, 2026.
Companies in 2026
By month
Product codes
DQKComputer, Diagnostic, Programmable3DQDStethoscope, Electronic2DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1DSIDetector And Alarm, Arrhythmia1DXHTransmitters And Receivers, Electrocardiograph, Telephone1MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1OBJCatheter, Ultrasound, Intravascular1QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate1All 15 devices
- EchoNextPathwai, Inc. · Cardiovascular
- ZEUS Platform (FG0501US)iRhythm Technologies, Inc. · Cardiovascular
- PCWP Analysis SoftwareCardiosense, Inc. · Cardiovascular
- Novasight Hybrid SystemConavi Medical, Inc. · Cardiovascular
- ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc. · Cardiovascular
- ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc. · Cardiovascular
- Tyto Stethoscope (G3)Tyto Care , Ltd. · Cardiovascular
- CARTO 3 EP Navigation System V8.4Biosense Webster, Inc. · Cardiovascular
- PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.) · Cardiovascular
- Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc. · Cardiovascular
- SafeBeat Rx AppSafeBeat Rx, Inc. · Cardiovascular
- Vital SignsOxehealth Limited · Cardiovascular
- BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc. · Cardiovascular
- Perin Health System (PHD80060-2)Perin Health Devices, LLC · Cardiovascular
- Corvair MonzaAliveCor, Inc. · Cardiovascular
Frequently asked questions
How many FDA-cleared AI cardiovascular devices were there in 2026?
Through June 29, 2026, 15 AI-enabled cardiovascular devices have a 2026 decision. That is 9.7% of all 154 cardiovascular devices on the list.
How does 2026 compare with 2025 for AI cardiovascular devices?
2026 is still in progress (FDA decisions through June 29, 2026): 15 cardiovascular AI devices so far, against 30 in all of 2025.
Which companies cleared the most AI cardiovascular devices in 2026?
Anumana, Inc. (2), AliveCor, Inc. (1), Biosense Webster, Inc. (1).
What was the most recent AI cardiovascular device in 2026?
EchoNext from Pathwai, Inc. (K260332), decided on June 8, 2026. Product code QXO.
Which product codes were most common for AI cardiovascular devices in 2026?
DQK (Computer, Diagnostic, Programmable): 3; DQD (Stethoscope, Electronic): 2; DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency): 1.
Cite as: AI Device Radar, “FDA-cleared AI devices for cardiovascular 2026,” https://ai-device-radar.vercel.app/specialty/cardiovascular/2026 (FDA list through 2026-06-29).