BrainSee is an AI-enabled medical device from Darmiyan, Inc. that the U.S. FDA granted through De Novo DEN220066 on January 11, 2024. Its lead review panel is Neurology and its primary product code is QWT (Prognostic Assessment Software Of Mild Cognitive Impairment).
See also FDA-cleared AI neurology devices in 2024, all FDA AI clearances in 2024, top neurology AI devices.
Key facts
| Submission number | DEN220066 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Darmiyan, Inc. |
| Lead review panel | Neurology |
| Primary product code | QWT — Prognostic Assessment Software Of Mild Cognitive Impairment |
| Applicant (openFDA) | Darmiyan, Inc. |
| Applicant location | Berkeley, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 882.1454 |
| 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. BrainSee went through this pathway (DEN220066).
openFDA lists it as a Class 2 device under 21 CFR 882.1454. Class II devices are moderate risk and are subject to general and special controls.
Product code QWT covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Darmiyan, Inc. has 1 AI-enabled device on the list, and the Neurology panel accounts for 73 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.