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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 / June 2026 / K260402

510(k) cleared

MeRT System

Wave Neuroscience · Jun 3, 2026 · K260402

FDA cleared the MeRT System from Wave Neuroscience on Jun 3, 2026 under K260402, a traditional 510(k). The device falls under product code SIG, Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd), regulated at 21 CFR 882.5802 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 6, 2026. The decision came 117 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 Wave Neuroscience in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260402?

K260402 is the FDA 510(k) for MeRT System, submitted by Wave Neuroscience. FDA's decision date was Jun 3, 2026, under product code SIG (Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)).

Who makes the MeRT System?

Wave Neuroscience, based in Newport Beach, CA, is the applicant of record for K260402.

How long did the K260402 review take?

FDA received the submission on Feb 6, 2026 and issued its decision on Jun 3, 2026, 117 days later.

← All decisions in June 2026