FDA-cleared AI devices for cardiovascular 2022
2022 has 14 cardiovascular AI devices, 27.3% more than 2021 (11). That is 9.1% of the 154 cardiovascular devices on the FDA list, and 8.6% of all AI-device decisions dated 2022. The most active were AliveCor, Inc. (1), Apple Inc. (1), Avive Solutions, Inc. (1). The newest is STAR Apollo Mapping System from Rhythm Al, Ltd, decided on December 1, 2022.
Companies in 2022
By month
Product codes
DQKComputer, Diagnostic, Programmable4DQDStethoscope, Electronic2PJACoronary Vascular Physiologic Simulation Software2DXHTransmitters And Receivers, Electrocardiograph, Telephone1MKJCode1MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)1QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use1QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate1All 14 devices
- STAR Apollo Mapping SystemRhythm Al, Ltd · Cardiovascular
- Avive Automated External Defibrillator (AED) SystemAvive Solutions, Inc. · Cardiovascular
- HeartFlow AnalysisHeartFlow, Inc. · Cardiovascular
- LINQ II Insertable Cardiac MonitorMedtronic, Inc. · Cardiovascular
- DeepRhythmAIMedicalgorithmics S.A. · Cardiovascular
- ZEUS System (Zio Watch)iRhythm Technologies, Inc. · Cardiovascular
- Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences LLC · Cardiovascular
- AHI SystemFifth Eye Inc. · Cardiovascular
- Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · Cardiovascular
- Atrial Fibrillation History FeatureApple Inc. · Cardiovascular
- eMurmur Heart AICSD Labs GmbH · Cardiovascular
- Oxehealth Vital SignsOxehealth Limited · Cardiovascular
- AliveCor QT ServiceAliveCor, Inc. · Cardiovascular
- DEEPVESSEL FFRKeyaMed NA Inc. · Cardiovascular
Frequently asked questions
How many FDA-cleared AI cardiovascular devices were there in 2022?
14 AI-enabled cardiovascular devices have a final decision dated 2022, from 14 companies.
How does 2022 compare with 2021 for AI cardiovascular devices?
2022 has 14 cardiovascular AI devices, 27.3% more than 2021 (11).
Which companies cleared the most AI cardiovascular devices in 2022?
AliveCor, Inc. (1), Apple Inc. (1), Avive Solutions, Inc. (1).
What was the most recent AI cardiovascular device in 2022?
STAR Apollo Mapping System from Rhythm Al, Ltd (K220786), decided on December 1, 2022. Product code DQK.
Which product codes were most common for AI cardiovascular devices in 2022?
DQK (Computer, Diagnostic, Programmable): 4; DQD (Stethoscope, Electronic): 2; PJA (Coronary Vascular Physiologic Simulation Software): 2.
Cite as: AI Device Radar, “FDA-cleared AI devices for cardiovascular 2022,” https://ai-device-radar.vercel.app/specialty/cardiovascular/2022 (FDA list through 2026-06-29).