FDA-cleared AI devices for cardiovascular 2020
2020 has 8 cardiovascular AI devices, 46.7% fewer than 2019 (15). That is 5.2% of the 154 cardiovascular devices on the FDA list, and 7% of all AI-device decisions dated 2020. The most active were AliveCor, Inc. (1), Eko Devices, Inc. (1), M3DICINE Pty Ltd. (1). The newest is KardiaAI from AliveCor, Inc., decided on November 12, 2020.
Companies in 2020
By month
Product codes
DQKComputer, Diagnostic, Programmable2DPSElectrocardiograph1DQDStethoscope, Electronic1DSIDetector And Alarm, Arrhythmia1DXHTransmitters And Receivers, Electrocardiograph, Telephone1MLOElectrocardiograph, Ambulatory, With Analysis Algorithm1MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1All 8 devices
- KardiaAIAliveCor, Inc. · Cardiovascular
- Stethee Pro 1, Stethee Pro Software SystemM3DICINE Pty Ltd. · Cardiovascular
- VX1Volta Medical · Cardiovascular
- RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant Inc. · Cardiovascular
- BodyGuardian Remote Monitoring SystemPreventice Technologies, Inc. · Cardiovascular
- AI-ECG TrackerShenzhen Carewell Electronics Co., Ltd. · Cardiovascular
- Study Watch with Irregular Pulse MonitorVerily Life Sciences LLC · Cardiovascular
- Eko Analysis SoftwareEko Devices Inc · Cardiovascular
Frequently asked questions
How many FDA-cleared AI cardiovascular devices were there in 2020?
8 AI-enabled cardiovascular devices have a final decision dated 2020, from 8 companies.
How does 2020 compare with 2019 for AI cardiovascular devices?
2020 has 8 cardiovascular AI devices, 46.7% fewer than 2019 (15).
Which companies cleared the most AI cardiovascular devices in 2020?
AliveCor, Inc. (1), Eko Devices, Inc. (1), M3DICINE Pty Ltd. (1).
What was the most recent AI cardiovascular device in 2020?
KardiaAI from AliveCor, Inc. (K201985), decided on November 12, 2020. Product code DQK.
Which product codes were most common for AI cardiovascular devices in 2020?
DQK (Computer, Diagnostic, Programmable): 2; DPS (Electrocardiograph): 1; DQD (Stethoscope, Electronic): 1.
Cite as: AI Device Radar, “FDA-cleared AI devices for cardiovascular 2020,” https://ai-device-radar.vercel.app/specialty/cardiovascular/2020 (FDA list through 2026-06-29).