FDA-cleared AI devices for cardiovascular 2017
2017 has 7 cardiovascular AI devices, 75% more than 2016 (4). That is 4.5% of the 154 cardiovascular devices on the FDA list, and 25.9% of all AI-device decisions dated 2017. The most active were ImpediMed Limited (2), Cardiologs Technologies (1), Medtronic, Inc. (1). The newest is SOZO from ImpediMed Limited, decided on December 22, 2017.
Companies in 2017
By month
Product codes
DPSElectrocardiograph1DPTProbe, Blood-Flow, Extravascular1DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1DSBPlethysmograph, Impedance1DSHRecorder, Magnetic Tape, Medical1MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)1OBHMonitor, Extracellular Fluid, Lymphedema, Extremity1All 7 devices
- SOZOImpediMed Limited · Cardiovascular
- Rooti Rx ECG Event Recorder, Rooti Link APP SoftwareRooti Labs Ltd. · Cardiovascular
- Peerbridge Cor(TM) SystemPeerbridge Health INc. · Cardiovascular
- SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0SPECTRALMD, INC. · Cardiovascular
- SOZOImpediMed Limited · Cardiovascular
- CardioLogs ECG Analysis PlatformCardiologs Technologies · Cardiovascular
- Reveal LINQMedtronic, Inc. · Cardiovascular
Frequently asked questions
How many FDA-cleared AI cardiovascular devices were there in 2017?
7 AI-enabled cardiovascular devices have a final decision dated 2017, from 6 companies.
How does 2017 compare with 2016 for AI cardiovascular devices?
2017 has 7 cardiovascular AI devices, 75% more than 2016 (4).
Which companies cleared the most AI cardiovascular devices in 2017?
ImpediMed Limited (2), Cardiologs Technologies (1), Medtronic, Inc. (1).
What was the most recent AI cardiovascular device in 2017?
SOZO from ImpediMed Limited (K172507), decided on December 22, 2017. Product code DSB.
Which product codes were most common for AI cardiovascular devices in 2017?
DPS (Electrocardiograph): 1; DPT (Probe, Blood-Flow, Extravascular): 1; DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency): 1.
Cite as: AI Device Radar, “FDA-cleared AI devices for cardiovascular 2017,” https://ai-device-radar.vercel.app/specialty/cardiovascular/2017 (FDA list through 2026-06-29).