ArteraAI Prostate is an AI-enabled medical device from Artera Inc. that the U.S. FDA granted through De Novo DEN240068 on July 31, 2025. Its lead review panel is Pathology and its primary product code is SFH (Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis).
See also all FDA AI clearances in 2025.
Key facts
| Submission number | DEN240068 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Artera Inc. |
| Lead review panel | Pathology |
| Primary product code | SFH — Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis |
| Applicant (openFDA) | Artera, Inc. |
| Applicant location | Los Altos, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 864.3755 |
| 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. ArteraAI Prostate went through this pathway (DEN240068).
openFDA lists it as a Class 2 device under 21 CFR 864.3755. Class II devices are moderate risk and are subject to general and special controls.
Product code SFH covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Artera Inc. has 2 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.