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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 / April 2026 / K260976

510(k) cleared

NeuroBlate System

Monteris Medical · Apr 23, 2026 · K260976

FDA cleared the NeuroBlate System from Monteris Medical on Apr 23, 2026 under K260976, a special 510(k). The device falls under product code ONO, Neurosurgical Laser With Mr Thermography, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Mar 24, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Monteris Medical has one other decision in the tracker over the last 12 months: K262315 (NeuroBlate System).

Questions & Answers

What did FDA clear under K260976?

K260976 is the FDA 510(k) for NeuroBlate System, submitted by Monteris Medical. FDA's decision date was Apr 23, 2026, under product code ONO (Neurosurgical Laser With Mr Thermography).

Who makes the NeuroBlate System?

Monteris Medical, based in Minnetonka, MN, is the applicant of record for K260976.

How long did the K260976 review take?

FDA received the submission on Mar 24, 2026 and issued its decision on Apr 23, 2026, 30 days later.

← All decisions in April 2026

Sources