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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 / K261849

510(k) cleared

VERAFEYE Imaging Catheter (VF-VIC-002)

Luma Vision Limited · Jul 24, 2026 · K261849 · In the directory

FDA cleared the VERAFEYE Imaging Catheter (VF-VIC-002) from Luma Vision Limited on Jul 24, 2026 under K261849, a special 510(k). The device falls under product code OBJ, Catheter, Ultrasound, Intravascular, regulated at 21 CFR 870.1200 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 3, 2026. The decision came 51 days later, inside the 90 FDA-day goal for a 510(k).

Luma Vision Limited has one other decision in the tracker over the last 12 months: K260885 (VERAFEYE Imaging and Guidance System (VF-VIS-002)).

Questions & Answers

What did FDA clear under K261849?

K261849 is the FDA 510(k) for VERAFEYE Imaging Catheter (VF-VIC-002), submitted by Luma Vision Limited. FDA's decision date was Jul 24, 2026, under product code OBJ (Catheter, Ultrasound, Intravascular).

Who makes the VERAFEYE Imaging Catheter (VF-VIC-002)?

Luma Vision Limited, based in Dublin, is the applicant of record for K261849. The company is listed in the MedDevice Startups directory.

How long did the K261849 review take?

FDA received the submission on Jun 3, 2026 and issued its decision on Jul 24, 2026, 51 days later.

← All decisions in July 2026

Sources

In the startup directory

LUMA Vision

Cardiovascular · Dublin, Ireland