FDA-cleared AI devices for cardiovascular 2023
2023 has 21 cardiovascular AI devices, 50% more than 2022 (14). That is 13.6% of the 154 cardiovascular devices on the FDA list, and 9.3% of all AI-device decisions dated 2023. The most active were Medtronic, Inc. (3), Volta Medical (2), Alio, Inc. (1). The newest is LINQ II Insertable Cardiac Monitor from Medtronic, Inc., decided on December 6, 2023.
Companies in 2023
By month
Product codes
DQKComputer, Diagnostic, Programmable4MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)3QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator2DPSElectrocardiograph1DQDStethoscope, Electronic1DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1QDAElectrocardiograph Software For Over-The-Counter Use1QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use1All 21 devices
- LINQ II Insertable Cardiac MonitorMedtronic, Inc. · Cardiovascular
- SignalHF (IM008)Implicity Inc. · Cardiovascular
- Vivio® LVEDP SystemAvicena, LLC · Cardiovascular
- Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc. · Cardiovascular
- Volta AF-XplorerVolta Medical · Cardiovascular
- Cleerly ISCHEMIACleerly, Inc · Cardiovascular
- CorVista® SystemCorVista Health, Inc. · Cardiovascular
- CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc. · Cardiovascular
- FaceHeart Vitals Software Development Kit (FH vitals SDK)FaceHeart Corp. · Cardiovascular
- Withings Scan Monitor 2.0Withings · Cardiovascular
- Viz HCMViz.ai, Inc. · Cardiovascular
- Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC · Cardiovascular
- Irregular Rhythm Notification Feature (IRNF)Apple Inc. · Cardiovascular
- AusculThing ACCAusculThing Oy · Cardiovascular
- Saranas Early Bird Bleed Monitoring SystemSaranas Inc. · Cardiovascular
- Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd · Cardiovascular
- LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc. · Cardiovascular
- Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification SystemMedtronic, Inc. · Cardiovascular
- AlioAlio, Inc. · Cardiovascular
- ZEUS SystemiRhythm Technologies, Inc. · Cardiovascular
- VX1+Volta Medical · Cardiovascular
Frequently asked questions
How many FDA-cleared AI cardiovascular devices were there in 2023?
21 AI-enabled cardiovascular devices have a final decision dated 2023, from 18 companies.
How does 2023 compare with 2022 for AI cardiovascular devices?
2023 has 21 cardiovascular AI devices, 50% more than 2022 (14).
Which companies cleared the most AI cardiovascular devices in 2023?
Medtronic, Inc. (3), Volta Medical (2), Alio, Inc. (1).
What was the most recent AI cardiovascular device in 2023?
LINQ II Insertable Cardiac Monitor from Medtronic, Inc. (K233562), decided on December 6, 2023. Product code MXD.
Which product codes were most common for AI cardiovascular devices in 2023?
DQK (Computer, Diagnostic, Programmable): 4; MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)): 3; QNL (Medium-Term Adjunctive Predictive Cardiovascular Indicator): 2.
Cite as: AI Device Radar, “FDA-cleared AI devices for cardiovascular 2023,” https://ai-device-radar.vercel.app/specialty/cardiovascular/2023 (FDA list through 2026-06-29).