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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / P250010

PMA approved

ProlivRx System

Neurolief , Ltd. · Dec 31, 2025 · P250010 · In the directory

FDA approved the ProlivRx System from Neurolief , Ltd. on Dec 31, 2025 under P250010, an original premarket approval. The device falls under product code JXK, Cranial Electrotherapy Stimulator To Treat Depression, regulated at 21 CFR 882.5800 as a Class 3 device. The review panel was Neurology.

FDA logged the submission as received on Mar 26, 2025. The decision came 280 days later.

This is the only decision on file for Neurolief , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P250010?

P250010 is the FDA PMA for ProlivRx System, submitted by Neurolief , Ltd.. FDA's decision date was Dec 31, 2025, under product code JXK (Cranial Electrotherapy Stimulator To Treat Depression).

Who makes the ProlivRx System?

Neurolief , Ltd., based in Netanya, is the applicant of record for P250010. The company is listed in the MedDevice Startups directory.

How long did the P250010 review take?

FDA received the submission on Mar 26, 2025 and issued its decision on Dec 31, 2025, 280 days later.

← All decisions in December 2025