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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 / November 2025 / DEN250015

510(k) cleared

Neurolyser XR (NXR100)

Fusmobile, Inc. · Nov 14, 2025 · DEN250015

FDA cleared the Neurolyser XR (NXR100) from Fusmobile, Inc. on Nov 14, 2025 under DEN250015, a direct 510(k). The device falls under product code SGN, High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation, regulated at 21 CFR 882.4420 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Apr 25, 2025. The decision came 203 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under DEN250015?

DEN250015 is the FDA 510(k) for Neurolyser XR (NXR100), submitted by Fusmobile, Inc.. FDA's decision date was Nov 14, 2025, under product code SGN (High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation).

Who makes the Neurolyser XR (NXR100)?

Fusmobile, Inc., based in Alpharetta, GA, is the applicant of record for DEN250015.

How long did the DEN250015 review take?

FDA received the submission on Apr 25, 2025 and issued its decision on Nov 14, 2025, 203 days later.

← All decisions in November 2025