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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 / September 2025 / K250689

510(k) cleared

CloudTMS Edge

Teleemg, LLC · Sep 14, 2025 · K250689

FDA cleared the CloudTMS Edge from Teleemg, LLC on Sep 14, 2025 under K250689, 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 Mar 6, 2025. The decision came 192 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 Teleemg, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250689?

K250689 is the FDA 510(k) for CloudTMS Edge, submitted by Teleemg, LLC. FDA's decision date was Sep 14, 2025, under product code OBP (Transcranial Magnetic Stimulator).

Who makes the CloudTMS Edge?

Teleemg, LLC, based in Los Angeles, CA, is the applicant of record for K250689.

How long did the K250689 review take?

FDA received the submission on Mar 6, 2025 and issued its decision on Sep 14, 2025, 192 days later.

← All decisions in September 2025