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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 / Orthopedics & Spine

Orthopedics & Spine

Allevion Medical

Boca Raton, FL · Unknown · 510(k) cleared

Sells the Vantage Lumbar Decompression Kit, a fully disposable sterile system for minimally invasive laminotomy and laminectomy with depth-controlled bone removal and integrated illumination. SurGenTec took exclusive rights to the system in October 2026.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Mar 12, 26	K252546510(k)	VantageTM Lumbar Decompression Kit	Allevion Medical, LLC	Orthopedic	HRX

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