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THE TAPE

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 / Orthopedics & Spine

Orthopedics & Spine Drug Delivery & Infusion

Brixton Biosciences

Cambridge, MA · Series B · De Novo granted

Cambridge, Massachusetts spin-out from Mass General Brigham developing ReneuRx (Neural Ice), an injectable, drug-free thermal nerve block for musculoskeletal pain. FDA granted De Novo DEN250067 on August 21, 2026, creating product code SJA under 21 CFR 888.3048.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Aug 21, 26	DEN250067510(k)	ReneuRx (Neural Ice)	Brixton Biosciences	Orthopedic	SJA

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