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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 / August 2026 / K261668

510(k) cleared

Venue Go

GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · Aug 7, 2026 · K261668

FDA cleared the Venue Go from GE Medical Systems Ultrasound and Primary care Diagnostics, LLC on Aug 7, 2026 under K261668, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 20, 2026. The decision came 79 days later, inside the 90 FDA-day goal for a 510(k).

GE Medical Systems Ultrasound and Primary care Diagnostics, LLC has 8 other decisions in the tracker over the last 12 months: K261933 (Voluson Expert 18; Voluson Expert 20; Voluson Expert 22), K261623 (EchoPAC Software Only / EchoPAC Plug-in (v211)), K261313 (Vivid Explorer/Vivid Advanced/Vivid Focus), K261835 (LOGIQ Focus).

Questions & Answers

What did FDA clear under K261668?

K261668 is the FDA 510(k) for Venue Go, submitted by GE Medical Systems Ultrasound and Primary care Diagnostics, LLC. FDA's decision date was Aug 7, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Venue Go?

GE Medical Systems Ultrasound and Primary care Diagnostics, LLC, based in Waukesha, WI, is the applicant of record for K261668.

How long did the K261668 review take?

FDA received the submission on May 20, 2026 and issued its decision on Aug 7, 2026, 79 days later.

← All decisions in August 2026