Roundup · ranked by clearances

Best FDA-cleared AI cardiovascular devices (2026)

The companies with the most FDA-cleared AI cardiovascular devices through June 29, 2026 are HeartFlow, Inc. (7), Medtronic, Inc. (7) and AliveCor, Inc. (6). This is a count of final decisions on the FDA list. It is not a ranking of clinical performance.

How this ranking works

Each row is one applicant name on the FDA AI-enabled device list, limited to devices whose lead review panel is Cardiovascular. Affiliated companies are not merged. A company needs at least two cardiovascular devices to appear in the top list. 65 other companies have exactly one. The full catalog is the cardiovascular specialty page; 2026 alone is FDA-cleared AI devices for cardiovascular 2026.

Top companies

  1. 1

    HeartFlow, Inc.

    HeartFlow, Inc. has 7 FDA-listed AI cardiovascular devices (4.5% of this specialty), with decisions from 2016–2025. The latest is HeartFlow Analysis (K250902) on July 18, 2025. Most common product code: PJA (Coronary Vascular Physiologic Simulation Software), 7 devices.

  2. 2

    Medtronic, Inc.

    Medtronic, Inc. has 7 FDA-listed AI cardiovascular devices (4.5% of this specialty), with decisions from 2017–2025. The latest is Aurora EV ICD (DVEA3E4) (P220012/S059) on October 28, 2025. Most common product code: MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)), 6 devices.

  3. 3

    AliveCor, Inc.

    AliveCor, Inc. has 6 FDA-listed AI cardiovascular devices (3.9% of this specialty), with decisions from 2019–2026. The latest is Corvair Monza (K252589) on January 9, 2026. Most common product code: DQK (Computer, Diagnostic, Programmable), 3 devices.

  4. 4

    iRhythm Technologies, Inc.

    iRhythm Technologies, Inc. has 6 FDA-listed AI cardiovascular devices (3.9% of this specialty), with decisions from 2018–2026. The latest is ZEUS Platform (FG0501US) (K252859) on May 29, 2026. Most common product code: DQK (Computer, Diagnostic, Programmable), 6 devices.

  5. 5

    Oxehealth Limited

    Oxehealth Limited has 5 FDA-listed AI cardiovascular devices (3.2% of this specialty), with decisions from 2021–2026. The latest is Vital Signs (K251200) on February 2, 2026. Most common product code: QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate), 5 devices.

  6. 6

    Volta Medical

    Volta Medical has 5 FDA-listed AI cardiovascular devices (3.2% of this specialty), with decisions from 2020–2025. The latest is Volta AF-Xplorer II (K251518) on September 12, 2025. Most common product code: DQK (Computer, Diagnostic, Programmable), 5 devices.

  7. 7

    Anumana, Inc.

    Anumana, Inc. has 4 FDA-listed AI cardiovascular devices (2.6% of this specialty), with decisions from 2023–2026. The latest is ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) (K253801) on April 7, 2026. Most common product code: QYE (Reduced Ejection Fraction Machine Learning-Based Notification Software), 2 devices.

  8. 8

    Apple Inc.

    Apple Inc. has 4 FDA-listed AI cardiovascular devices (2.6% of this specialty), with decisions from 2021–2025. The latest is Hypertension Notification Feature (HTNF) (K250507) on September 11, 2025. Most common product code: QDB (Photoplethysmograph Analysis Software For Over-The-Counter Use), 3 devices.

Newest cardiovascular clearances

The six most recent cardiovascular decisions on the list. See every cardiovascular device dated 2026 · All specialties in 2026

Radiology1230Neurology73Anesthesiology30Gastroenterology-Urology27Hematology22

Frequently asked questions

Which company has the most FDA-cleared AI cardiovascular devices?

HeartFlow, Inc. has the most, with 7 (4.5% of cardiovascular devices on the list). Next are Medtronic, Inc. (7) and AliveCor, Inc. (6).

How many FDA-cleared AI cardiovascular devices are there?

The FDA AI-device list has 154 devices with Cardiovascular as the lead review panel, from 92 companies, through June 29, 2026.

Is this a ranking of the best AI cardiovascular devices clinically?

No. Companies are ordered by how many FDA final decisions they have on the AI-enabled device list. That measures how many authorized products an applicant has, not accuracy, safety, or which device to buy.

Which AI cardiovascular device was cleared most recently?

EchoNext from Pathwai, Inc. (K260332), decided on June 8, 2026.

How many AI cardiovascular devices were cleared in 2026?

15 cardiovascular devices have a 2026 decision date, through June 29, 2026.

Cite as: AI Device Radar, “Best FDA-cleared AI cardiovascular devices (2026),” https://ai-device-radar.vercel.app/best/cardiovascular (FDA list through 2026-06-29).