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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 / July 2026 / K253835

510(k) cleared

Affinity

Hermes Medical Solutions AB · Jul 31, 2026 · K253835

FDA cleared the Affinity from Hermes Medical Solutions AB on Jul 31, 2026 under K253835, 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 Dec 1, 2025. The decision came 242 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 Hermes Medical Solutions AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253835?

K253835 is the FDA 510(k) for Affinity, submitted by Hermes Medical Solutions AB. FDA's decision date was Jul 31, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Affinity?

Hermes Medical Solutions AB, based in Stockholm, is the applicant of record for K253835.

How long did the K253835 review take?

FDA received the submission on Dec 1, 2025 and issued its decision on Jul 31, 2026, 242 days later.

← All decisions in July 2026