FDA-cleared AI devices for cardiovascular 2024
2024 has 15 cardiovascular AI devices, 28.6% fewer than 2023 (21). That is 9.7% of the 154 cardiovascular devices on the FDA list, and 6.4% of all AI-device decisions dated 2024. The most active were AliveCor, Inc. (2), Ultromics Limited (2), AgileMD, Inc. (1). The newest is DeepRhythmAI from Medicalgorithmics S.A., decided on December 4, 2024.
Companies in 2024
By month
Product codes
DQKComputer, Diagnostic, Programmable2QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator2DPSElectrocardiograph1MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1MWJElectrocardiograph, Ambulatory (Without Analysis)1QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate1QMSAdjunctive Open Loop Fluid Therapy Recommender1QUOAdjunctive Heart Failure Status Indicator1All 15 devices
- DeepRhythmAIMedicalgorithmics S.A. · Cardiovascular
- Informed Vital Core Application (IVC App)Mindset Medical, Inc. · Cardiovascular
- EchoGo Amyloidosis (1.0)Ultromics Limited · Cardiovascular
- EchoGo Heart Failure (2.0)Ultromics Limited · Cardiovascular
- HeartKey® RhythmB-Secur Limited · Cardiovascular
- Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC · Cardiovascular
- eCARTv5 Clinical Deterioration Suite (eCART)AgileMD, Inc. · Cardiovascular
- Tempus ECG-AFTempus AI, Inc. · Cardiovascular
- ImpalaAliveCor, Inc. · Cardiovascular
- CorvairAliveCor, Inc. · Cardiovascular
- ASSURE Wearable ECGKestra Medical Technologies, Inc. · Cardiovascular
- CorVista System with PH Add-OnAnalytics for Life, Inc. · Cardiovascular
- APPRAISE-HRIThe Surgeon General, Department of the Army (TSG-DA) · Cardiovascular
- Eko Low Ejection Fraction Tool (ELEFT)Eko Health, Inc. · Cardiovascular
- CLEWICU SystemClew Medical Ltd. · Cardiovascular
Frequently asked questions
How many FDA-cleared AI cardiovascular devices were there in 2024?
15 AI-enabled cardiovascular devices have a final decision dated 2024, from 13 companies.
How does 2024 compare with 2023 for AI cardiovascular devices?
2024 has 15 cardiovascular AI devices, 28.6% fewer than 2023 (21).
Which companies cleared the most AI cardiovascular devices in 2024?
AliveCor, Inc. (2), Ultromics Limited (2), AgileMD, Inc. (1).
What was the most recent AI cardiovascular device in 2024?
DeepRhythmAI from Medicalgorithmics S.A. (K241197), decided on December 4, 2024. Product code DQK.
Which product codes were most common for AI cardiovascular devices in 2024?
DQK (Computer, Diagnostic, Programmable): 2; QNL (Medium-Term Adjunctive Predictive Cardiovascular Indicator): 2; DPS (Electrocardiograph): 1.
Cite as: AI Device Radar, “FDA-cleared AI devices for cardiovascular 2024,” https://ai-device-radar.vercel.app/specialty/cardiovascular/2024 (FDA list through 2026-06-29).