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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 / September 2026 / K261225

510(k) cleared

CAS-One IR

Cascination AG · Sep 29, 2026 · K261225

FDA cleared the CAS-One IR from Cascination AG on Sep 29, 2026 under K261225, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 15, 2026. The decision came 167 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 Cascination AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261225?

K261225 is the FDA 510(k) for CAS-One IR, submitted by Cascination AG. FDA's decision date was Sep 29, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the CAS-One IR?

Cascination AG, based in Bern, is the applicant of record for K261225.

How long did the K261225 review take?

FDA received the submission on Apr 15, 2026 and issued its decision on Sep 29, 2026, 167 days later.

← All decisions in September 2026