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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 / October 2025 / DEN240076

510(k) cleared

Modius Lean

Neurovalens Limited · Oct 17, 2025 · DEN240076

FDA cleared the Modius Lean from Neurovalens Limited on Oct 17, 2025 under DEN240076, a direct 510(k). The device falls under product code SFW, Cranial Electrotherapy Stimulator For Weight Management, regulated at 21 CFR 876.5984 as a Class 1 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 18, 2024. The decision came 303 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Neurovalens Limited has one other decision in the tracker over the last 12 months: DEN250013 (Modius Spero).

Questions & Answers

What did FDA clear under DEN240076?

DEN240076 is the FDA 510(k) for Modius Lean, submitted by Neurovalens Limited. FDA's decision date was Oct 17, 2025, under product code SFW (Cranial Electrotherapy Stimulator For Weight Management).

Who makes the Modius Lean?

Neurovalens Limited, based in Portglenone, is the applicant of record for DEN240076.

How long did the DEN240076 review take?

FDA received the submission on Dec 18, 2024 and issued its decision on Oct 17, 2025, 303 days later.

← All decisions in October 2025