Genius Digital Diagnostics System with the Genius Cervical AI algorithm is an AI-enabled medical device from Hologic Inc. that the U.S. FDA granted through De Novo DEN210035 on January 31, 2024. Its lead review panel is Pathology and its primary product code is QYV (Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm).
See also all FDA AI clearances in 2024.
Key facts
| Submission number | DEN210035 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Hologic Inc. |
| Lead review panel | Pathology |
| Primary product code | QYV — Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm |
| Applicant (openFDA) | Hologic, Inc. |
| Applicant location | Malborough, MA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 864.3900 |
| 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. Genius Digital Diagnostics System with the Genius Cervical AI algorithm went through this pathway (DEN210035).
openFDA lists it as a Class 2 device under 21 CFR 864.3900. Class II devices are moderate risk and are subject to general and special controls.
Product code QYV covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Hologic Inc. has 9 AI-enabled devices on the list, and the Pathology panel accounts for 10 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.