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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

Empirical Spine

San Carlos, CA · Series B · PMA approved

Empirical Spine makes LimiFlex, a tension band implanted after lumbar decompression to stabilize the segment without fusion. The device came out of Stanford Biodesign and has a 2009 CE mark.

FDA DECISIONS ON FILE

2 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Jun 16, 26	K253374510(k)	LimiFlex® Dynamic Sagittal Tether Instrument Set	Empirical Spine	Orthopedic	SGL
Feb 12, 26	P220031PMA	LimiFlex Dynamic Sagittal Tether	Empirical Spine, Inc.	Orthopedic	SGK

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Empirical Spine

FDA DECISIONS ON FILE

COVERAGE