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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 / Diabetes & Metabolic

Diabetes & Metabolic Drug Delivery & Infusion

Modular Medical

San Diego, CA · Public · 510(k) cleared

Builds Pivot, a tubeless insulin patch pump that delivers basal and bolus insulin over a three-day wear period. Aimed at people with diabetes who have not adopted existing pumps.

FDA DECISIONS ON FILE

2 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Sep 2, 26	K262153510(k)	Pivot Insulin Delivery System	Modular Medical, Inc.	General Hospital	LZG
Apr 8, 26	K253534510(k)	Pivot Insulin Delivery System	Modular Medical	General Hospital	LZG

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Modular Medical

FDA DECISIONS ON FILE

COVERAGE