FDA-cleared AI devices for cardiovascular 2018
2018 has 10 cardiovascular AI devices, 42.9% more than 2017 (7). That is 6.5% of the 154 cardiovascular devices on the FDA list, and 15.4% of all AI-device decisions dated 2018. The most active were Cardio-Phoenix Inc. (1), CathWorks Ltd (1), Edwards Lifesciences, LLC (1). The newest is FFRangio System from CathWorks Ltd, decided on December 19, 2018.
Companies in 2018
By month
Product codes
DQKComputer, Diagnostic, Programmable2MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2DPSElectrocardiograph1DXHTransmitters And Receivers, Electrocardiograph, Telephone1OBHMonitor, Extracellular Fluid, Lymphedema, Extremity1PJACoronary Vascular Physiologic Simulation Software1QAQAdjunctive Predictive Cardiovascular Indicator1QEKAngiographic Coronary Vascular Physiologic Simulation Software1All 10 devices
- FFRangio SystemCathWorks Ltd · Cardiovascular
- Cardio-TriTest v6.5Cardio-Phoenix Inc. · Cardiovascular
- FFRctHeartFlow, Inc · Cardiovascular
- AI-ECG PlatformShenzhen Carewell Electronics., Ltd · Cardiovascular
- FibriCheckQompium nv · Cardiovascular
- Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · Cardiovascular
- PeraServer and PeraTrendPeraHealth, Inc. · Cardiovascular
- SOZOImpediMed Limited · Cardiovascular
- Acumen Hypotension Prediction Index (HPI) Feature SoftwareEdwards Lifesciences LLC · Cardiovascular
- WAVE Clinical PlatformExcel Medical Electronics, LLC · Cardiovascular
Frequently asked questions
How many FDA-cleared AI cardiovascular devices were there in 2018?
10 AI-enabled cardiovascular devices have a final decision dated 2018, from 10 companies.
How does 2018 compare with 2017 for AI cardiovascular devices?
2018 has 10 cardiovascular AI devices, 42.9% more than 2017 (7).
Which companies cleared the most AI cardiovascular devices in 2018?
Cardio-Phoenix Inc. (1), CathWorks Ltd (1), Edwards Lifesciences, LLC (1).
What was the most recent AI cardiovascular device in 2018?
FFRangio System from CathWorks Ltd (K182149), decided on December 19, 2018. Product code QEK.
Which product codes were most common for AI cardiovascular devices in 2018?
DQK (Computer, Diagnostic, Programmable): 2; MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)): 2; DPS (Electrocardiograph): 1.
Cite as: AI Device Radar, “FDA-cleared AI devices for cardiovascular 2018,” https://ai-device-radar.vercel.app/specialty/cardiovascular/2018 (FDA list through 2026-06-29).