FDA-cleared AI devices for cardiovascular 2019
2019 has 15 cardiovascular AI devices, 50% more than 2018 (10). That is 9.7% of the 154 cardiovascular devices on the FDA list, and 18.8% of all AI-device decisions dated 2019. The most active were Biofourmis Singapore Pte. Ltd (2), AliveCor, Inc. (1), CathWorks Ltd (1). The newest is FFRangio from CathWorks Ltd, decided on December 9, 2019.
Companies in 2019
By month
Product codes
DQKComputer, Diagnostic, Programmable3DXHTransmitters And Receivers, Electrocardiograph, Telephone2DPSElectrocardiograph1DQAOximeter1DQDStethoscope, Electronic1MUDOximeter, Tissue Saturation1MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1PJACoronary Vascular Physiologic Simulation Software1All 15 devices
- FFRangioCathWorks Ltd · Cardiovascular
- SOZOImpediMed Limited · Cardiovascular
- MIMOSA ImagerMIMOSA Diagnostics Inc · Cardiovascular
- PeraMobile and PeraWatchPeraHealth, Inc. · Cardiovascular
- Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · Cardiovascular
- HeartFlow FFRct AnalysisHeartFlow, Inc. · Cardiovascular
- Biovitals Analytics EngineBiofourmis Singapore Pte. Ltd · Cardiovascular
- physIQ Heart Rhythm and Respiratory ModulephysIQ, Inc · Cardiovascular
- Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - PressureEdwards Lifeciences, LLC · Cardiovascular
- eMurmur IDCSD Labs GmbH · Cardiovascular
- Loop SystemSpry Health, Inc. · Cardiovascular
- KardiaAIAliveCor, Inc. · Cardiovascular
- RhythmAnalyticsBiofourmis Singapore Pte. Ltd. · Cardiovascular
- RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant Inc. · Cardiovascular
- Study WatchVerily Life Sciences LLC · Cardiovascular
Frequently asked questions
How many FDA-cleared AI cardiovascular devices were there in 2019?
15 AI-enabled cardiovascular devices have a final decision dated 2019, from 14 companies.
How does 2019 compare with 2018 for AI cardiovascular devices?
2019 has 15 cardiovascular AI devices, 50% more than 2018 (10).
Which companies cleared the most AI cardiovascular devices in 2019?
Biofourmis Singapore Pte. Ltd (2), AliveCor, Inc. (1), CathWorks Ltd (1).
What was the most recent AI cardiovascular device in 2019?
FFRangio from CathWorks Ltd (K192442), decided on December 9, 2019. Product code QEK.
Which product codes were most common for AI cardiovascular devices in 2019?
DQK (Computer, Diagnostic, Programmable): 3; DXH (Transmitters And Receivers, Electrocardiograph, Telephone): 2; DPS (Electrocardiograph): 1.
Cite as: AI Device Radar, “FDA-cleared AI devices for cardiovascular 2019,” https://ai-device-radar.vercel.app/specialty/cardiovascular/2019 (FDA list through 2026-06-29).