Gili Pro BioSensor (also known as Gili BioSensor System) is an AI-enabled medical device from ContinUse Biometrics Ltd. that the U.S. FDA granted through De Novo DEN200038 on April 1, 2021. Its lead review panel is Cardiovascular and its primary product code is QOK (Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate).
See also FDA-cleared AI cardiovascular devices in 2021, all FDA AI clearances in 2021, top cardiovascular AI devices.
Key facts
| Submission number | DEN200038 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | ContinUse Biometrics Ltd. |
| Lead review panel | Cardiovascular |
| Primary product code | QOK — Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate |
| Applicant (openFDA) | Continuse Biometrics , Ltd. |
| Applicant location | Tel-Aviv, IL |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.2786 |
| Decision code | DENG |
| Submission type | Direct |
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. Gili Pro BioSensor (also known as Gili BioSensor System) went through this pathway (DEN200038).
openFDA lists it as a Class 2 device under 21 CFR 870.2786. Class II devices are moderate risk and are subject to general and special controls.
Product code QOK covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. ContinUse Biometrics Ltd. has 1 AI-enabled device 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.