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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 / October 2026 / K261733

510(k) cleared

Ligence Heart

UAB Ligence · Oct 7, 2026 · K261733

FDA cleared the Ligence Heart from UAB Ligence on Oct 7, 2026 under K261733, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 26, 2026. The decision came 134 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 UAB Ligence in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261733?

K261733 is the FDA 510(k) for Ligence Heart, submitted by UAB Ligence. FDA's decision date was Oct 7, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Ligence Heart?

UAB Ligence, based in Kaunas, is the applicant of record for K261733.

How long did the K261733 review take?

FDA received the submission on May 26, 2026 and issued its decision on Oct 7, 2026, 134 days later.

← All decisions in October 2026