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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 Directory / Imaging & Radiology

Imaging & Radiology Digital Health & SaMD

Rivanna Medical

Charlottesville, VA · Unknown · 510(k) cleared

Makes the Accuro handheld ultrasound system for spinal anesthesia guidance and SpineNav-AI, machine learning software that identifies lumbar spine structures and the spine midline in ultrasound images.

FDA DECISIONS ON FILE

3 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Jul 24, 26	K253452510(k)	Accuro 3S	Rivanna Medical, Inc.	Radiology	IYO
Jul 24, 26	K261014510(k)	Accuro® 3S Needle Guide Kit	Rivanna Medical, Inc.	Radiology	ITX
Apr 9, 26	K254021510(k)	Accuro XV	Rivanna Medical, Inc.	Radiology	IYO

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