DreaMed Advisor Pro is an AI-enabled medical device from DreaMed Diabetes, Ltd. that the U.S. FDA granted through De Novo DEN170043 on June 12, 2018. Its lead review panel is Clinical Chemistry and its primary product code is QCC (Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals).
See also all FDA AI clearances in 2018.
Key facts
| Submission number | DEN170043 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | DreaMed Diabetes, Ltd. |
| Lead review panel | Clinical Chemistry |
| Primary product code | QCC — Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals |
| Applicant (openFDA) | DreaMed Diabetes, Ltd. |
| Applicant location | Petah Tikva, Pob 3271, IL |
| Device class | Class 2 |
| Regulation number | 21 CFR 862.1358 |
| 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. DreaMed Advisor Pro went through this pathway (DEN170043).
openFDA lists it as a Class 2 device under 21 CFR 862.1358. Class II devices are moderate risk and are subject to general and special controls.
Product code QCC covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. DreaMed Diabetes, Ltd. has 2 AI-enabled devices on the list, and the Clinical Chemistry panel accounts for 9 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.