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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 / K260189

510(k) cleared

MagVenture Accelerated TMS (aTMS) Therapy System

Tonica Elektronik A/S · May 22, 2026 · K260189

FDA cleared the MagVenture Accelerated TMS (aTMS) Therapy System from Tonica Elektronik A/S on May 22, 2026 under K260189, a traditional 510(k). The device falls under product code OBP, Transcranial Magnetic Stimulator, regulated at 21 CFR 882.5805 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jan 22, 2026. The decision came 120 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 Tonica Elektronik A/S in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260189?

K260189 is the FDA 510(k) for MagVenture Accelerated TMS (aTMS) Therapy System, submitted by Tonica Elektronik A/S. FDA's decision date was May 22, 2026, under product code OBP (Transcranial Magnetic Stimulator).

Who makes the MagVenture Accelerated TMS (aTMS) Therapy System?

Tonica Elektronik A/S, based in Farum, is the applicant of record for K260189.

How long did the K260189 review take?

FDA received the submission on Jan 22, 2026 and issued its decision on May 22, 2026, 120 days later.

← All decisions in May 2026