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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 / January 2026 / K254010

510(k) cleared

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface

Brainlab SE · Jan 14, 2026 · K254010

FDA cleared the ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface from Brainlab SE on Jan 14, 2026 under K254010, a special 510(k). The device falls under product code IYE, Accelerator, Linear, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 15, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Brainlab SE has 2 other decisions in the tracker over the last 12 months: K261655 (RT Elements (4.6)), K262257 (Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine).

Questions & Answers

What did FDA clear under K254010?

K254010 is the FDA 510(k) for ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface, submitted by Brainlab SE. FDA's decision date was Jan 14, 2026, under product code IYE (Accelerator, Linear, Medical).

Who makes the ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface?

Brainlab SE, based in Munich, is the applicant of record for K254010.

How long did the K254010 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Jan 14, 2026, 30 days later.

← All decisions in January 2026

Sources