NEVISENSE is an AI-enabled medical device from SCIBASE AB that the U.S. FDA approved through PMA P150046 on June 28, 2017. Its lead review panel is General and Plastic Surgery and its primary product code is ONV.
See also all FDA AI clearances in 2017.
Key facts
| Submission number | P150046 |
|---|---|
| Pathway | PMA |
| Date of final decision | |
| Company (FDA list) | SCIBASE AB |
| Lead review panel | General and Plastic Surgery |
| Primary product code | ONV |
Source: FDA AI-Enabled Medical Devices list. No matching openFDA record was found for this submission yet.
What this means
Premarket Approval (PMA) is FDA's most stringent pathway, used for Class III devices. It requires valid scientific evidence of safety and effectiveness. NEVISENSE went through this pathway (P150046).
Product code ONV covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. SCIBASE AB has 1 AI-enabled device on the list, and the General and Plastic Surgery 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.