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Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

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 / Surgical & Robotics

Surgical & Robotics Orthopedics & Spine

Think Surgical

Fremont, CA · Growth · 510(k) cleared

Builds TMINI, a cordless handheld robotic system for total knee replacement that works from a CT based 3D plan and guides bone pin placement.

FDA DECISIONS ON FILE

3 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Jul 24, 26	K261024510(k)	TMINI Miniature Robotic System	THINK Surgical, Inc.	Neurology	OLO
Mar 3, 26	K260010510(k)	TMINI® Miniature Robotic System	THINK Surgical, Inc.	Neurology	OLO
Dec 22, 25	K253661510(k)	TMINI Miniature Robotic System	THINK Surgical, Inc.	Neurology	OLO

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Think Surgical

FDA DECISIONS ON FILE

COVERAGE