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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / November 2025 / K251391

510(k) cleared

BrainsWay Deep TMS System

Brainsway , Ltd. · Nov 7, 2025 · K251391

FDA cleared the BrainsWay Deep TMS System from Brainsway , Ltd. on Nov 7, 2025 under K251391, 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 May 5, 2025. The decision came 186 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 Brainsway , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251391?

K251391 is the FDA 510(k) for BrainsWay Deep TMS System, submitted by Brainsway , Ltd.. FDA's decision date was Nov 7, 2025, under product code OBP (Transcranial Magnetic Stimulator).

Who makes the BrainsWay Deep TMS System?

Brainsway , Ltd., based in Jerusalem, is the applicant of record for K251391.

How long did the K251391 review take?

FDA received the submission on May 5, 2025 and issued its decision on Nov 7, 2025, 186 days later.

← All decisions in November 2025