De Novo · Cardiovascular

Oxehealth Vital Signs

by Oxehealth Limited

Oxehealth Vital Signs is an AI-enabled medical device from Oxehealth Limited that the U.S. FDA granted through De Novo DEN200019 on March 26, 2021. Its lead review panel is Cardiovascular and its primary product code is QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate).

See also FDA-cleared AI cardiovascular devices in 2021, all FDA AI clearances in 2021, top cardiovascular AI devices.

Key facts

Submission numberDEN200019
PathwayDe Novo
Date of final decision
Company (FDA list)Oxehealth Limited
Lead review panelCardiovascular
Primary product codeQME — Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Applicant (openFDA)Oxehealth Limited
Applicant locationOxford, GB
Device classClass 2
Regulation number21 CFR 870.2785
Decision codeDENG
Submission typeDirect

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. Oxehealth Vital Signs went through this pathway (DEN200019).

openFDA lists it as a Class 2 device under 21 CFR 870.2785. Class II devices are moderate risk and are subject to general and special controls.

Product code QME covers 7 devices on the FDA AI list. By decision date, this device is #1 of 7 under that code. Oxehealth Limited has 6 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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