Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati is an AI-enabled medical device from Element Science, Inc. that the U.S. FDA approved through PMA P230022 on April 30, 2025. Its lead review panel is Cardiovascular and its primary product code is MVK.
See also FDA-cleared AI cardiovascular devices in 2025, all FDA AI clearances in 2025, top cardiovascular AI devices.
Key facts
| Submission number | P230022 |
|---|---|
| Pathway | PMA |
| Date of final decision | |
| Company (FDA list) | Element Science, Inc. |
| Lead review panel | Cardiovascular |
| Primary product code | MVK |
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. Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati went through this pathway (P230022).
Product code MVK covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Element Science, Inc. has 1 AI-enabled device on the list, and the Cardiovascular panel accounts for 154 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.