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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 / May 2026 / DEN250013

510(k) cleared

Modius Spero

Neurovalens Limited · May 8, 2026 · DEN250013

FDA cleared the Modius Spero from Neurovalens Limited on May 8, 2026 under DEN250013, a direct 510(k). The device falls under product code SHX, Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms, regulated at 21 CFR 882.5807 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Apr 16, 2025. The decision came 387 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: DEN240076 (Modius Lean).

Questions & Answers

What did FDA clear under DEN250013?

DEN250013 is the FDA 510(k) for Modius Spero, submitted by Neurovalens Limited. FDA's decision date was May 8, 2026, under product code SHX (Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms).

Who makes the Modius Spero?

Neurovalens Limited, based in Portglenone, is the applicant of record for DEN250013.

How long did the DEN250013 review take?

FDA received the submission on Apr 16, 2025 and issued its decision on May 8, 2026, 387 days later.

← All decisions in May 2026

Sources