FDA-cleared AI devices for cardiovascular 2021
2021 has 11 cardiovascular AI devices, 37.5% more than 2020 (8). That is 7.1% of the 154 cardiovascular devices on the FDA list, and 8.5% of all AI-device decisions dated 2021. The most active were Fifth Eye Inc. (2), Oxehealth Limited (2), Apple Inc. (1). The newest is AHI System from Fifth Eye Inc., decided on December 3, 2021.
Companies in 2021
By month
Product codes
DQKComputer, Diagnostic, Programmable2QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate2QNVAdjunctive Hemodynamic Indicator With Decision Point2MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)1PJACoronary Vascular Physiologic Simulation Software1QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use1QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator1QOKHardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate1All 11 devices
- AHI SystemFifth Eye Inc. · Cardiovascular
- IM007Implicity, Inc. · Cardiovascular
- IRNF AppApple Inc. · Cardiovascular
- Vital SignsOxehealth Limited · Cardiovascular
- LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc. · Cardiovascular
- Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc. · Cardiovascular
- Gili Pro BioSensor (also known as Gili BioSensor System)ContinUse Biometrics Ltd. · Cardiovascular
- Oxehealth Vital SignsOxehealth Limited · Cardiovascular
- Analytic for Hemodynamic Instability (AHI)Fifth Eye Inc. · Cardiovascular
- CLEWICU System (ClewICUServer and ClewICUnitor)CLEW Medical Ltd. · Cardiovascular
- HeartFlow AnalysisHeartFlow, Inc. · Cardiovascular
Frequently asked questions
How many FDA-cleared AI cardiovascular devices were there in 2021?
11 AI-enabled cardiovascular devices have a final decision dated 2021, from 9 companies.
How does 2021 compare with 2020 for AI cardiovascular devices?
2021 has 11 cardiovascular AI devices, 37.5% more than 2020 (8).
Which companies cleared the most AI cardiovascular devices in 2021?
Fifth Eye Inc. (2), Oxehealth Limited (2), Apple Inc. (1).
What was the most recent AI cardiovascular device in 2021?
AHI System from Fifth Eye Inc. (K212219), decided on December 3, 2021. Product code QNV.
Which product codes were most common for AI cardiovascular devices in 2021?
DQK (Computer, Diagnostic, Programmable): 2; QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate): 2; QNV (Adjunctive Hemodynamic Indicator With Decision Point): 2.
Cite as: AI Device Radar, “FDA-cleared AI devices for cardiovascular 2021,” https://ai-device-radar.vercel.app/specialty/cardiovascular/2021 (FDA list through 2026-06-29).