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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 / Diabetes & Metabolic

Diabetes & Metabolic Drug Delivery & Infusion

Sequel Med Tech

Manchester, NH · Unknown · 510(k) cleared

Sequel sells twiist, an automated insulin delivery pump that pairs with Abbott and Senseonics continuous glucose monitors and runs a dosing algorithm derived from Tidepool Loop.

FDA DECISIONS ON FILE

2 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Jun 17, 26	K261672510(k)	twiist Automated Insulin Delivery (AID) System	Deka Research and Development	Clinical Chemistry	QFG
Jun 3, 26	K261530510(k)	iiSure Infusion Set	Deka Research and Development	General Hospital	FPA

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Sequel Med Tech

FDA DECISIONS ON FILE

COVERAGE