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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

ZuriMED

Zurich, Switzerland · Acquired · 510(k) cleared

Zurich company behind the FiberLocker system, a mechanical rotator cuff augmentation that interweaves patch fibers into tendon tissue. FiberLocker received FDA clearance in February 2025, and Stryker signed a definitive agreement to acquire the company on August 31, 2026.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Jan 2, 26	K253867510(k)	FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit	ZuriMED Technologies AG	General, Plastic Surgery	OWX

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ZuriMED

FDA DECISIONS ON FILE

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