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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 / March 2026 / K260479

510(k) cleared

TheraSphere 360 Y-90 Management Platform

Boston Scientific Corporation · Mar 13, 2026 · K260479

FDA cleared the TheraSphere 360 Y-90 Management Platform from Boston Scientific Corporation on Mar 13, 2026 under K260479, a special 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 13, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Boston Scientific Corporation has 8 other decisions in the tracker over the last 12 months: K262151 (SpaceOAR Flex System), K262460 (Rezum System), K261153 (LithoVue Elite Digital Flexible Ureteroscope System), K253692 (AVVIGO+ Multi-Modality Guidance System).

Questions & Answers

What did FDA clear under K260479?

K260479 is the FDA 510(k) for TheraSphere 360 Y-90 Management Platform, submitted by Boston Scientific Corporation. FDA's decision date was Mar 13, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the TheraSphere 360 Y-90 Management Platform?

Boston Scientific Corporation, based in Marborough, MA, is the applicant of record for K260479.

How long did the K260479 review take?

FDA received the submission on Feb 13, 2026 and issued its decision on Mar 13, 2026, 28 days later.

← All decisions in March 2026