Specialty

FDA-cleared AI cardiovascular devices

The FDA's AI-enabled device list has 154 devices whose lead review panel is Cardiovascular, 9.5% of all 1,614 listed devices. They come from 100 companies. The first decision was on July 17, 2008 and the most recent on June 8, 2026.

154AI devices
92Companies
2008First decision
2026-06-08Latest decision

Guides for cardiovascular

Top cardiovascular AI devices2026152025302024152023212022142021112020820191520181020177

Trend: devices per year

2008: 12012: 12013: 12015: 12016: 42017: 72018: 102019: 152020: 82021: 112022: 142023: 212024: 152025: 302026: 15
'08'13'16'18'20'22'24'26
FDA-cleared AI cardiovascular devices per year: 2008 1, 2012 1, 2013 1, 2015 1, 2016 4, 2017 7, 2018 10, 2019 15, 2020 8, 2021 11, 2022 14, 2023 21, 2024 15, 2025 30, 2026 15

Top companies

Most common product codes

DQK28 devicesDQD14 devicesMXD8 devicesPJA8 devicesQME7 devicesDPS7 devicesDXH6 devicesQYE5 devices

All 154 devices, newest first

Frequently asked questions

How many FDA-cleared AI cardiovascular devices are there?

As of the FDA list updated through June 29, 2026, 154 AI-enabled devices have Cardiovascular as their lead review panel (9.5% of the list).

Which companies have the most AI cardiovascular devices?

Medtronic, Inc. (7), iRhythm Technologies, Inc. (6), AliveCor, Inc. (6) have the most AI-enabled cardiovascular devices on the FDA list.

Which year had the most AI cardiovascular authorizations?

2025 had the most, with 30 devices.

Which FDA pathways are used for AI cardiovascular devices?

510(k): 144; De Novo: 6; PMA: 4.

What was the most recent AI cardiovascular device on the list?

EchoNext from Pathwai, Inc. (K260332), with a decision dated June 8, 2026.