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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

CGM, insulin delivery and metabolic monitoring. 8 companies listed.

Pleasanton, CA  ·  Series B  ·  510(k) cleared

Radiofrequency vapor ablation delivered through an endoscope working channel. The system is cleared for GI tract ablation, and the company is testing a duodenal mucosal ablation procedure for type 2 diabetes under an FDA IDE.

Irvine, CA  ·  Public  ·  510(k) cleared

Makes the iLet automated insulin delivery system and the Mint patch pump, both of which dose insulin from continuous glucose monitor data.

San Diego, CA  ·  Series C  ·  510(k) cleared

Makes Biolinq Shine, a needle-free forearm patch whose microsensor array reads glucose from the top layers of skin. A color-coded LED on the patch shows the glucose range without a phone, and the device also logs activity and sleep.

Minneapolis, MN  ·  Est. 2017  ·  Series C  ·  Breakthrough designation

Develops ReCET, an endoscopic catheter that applies non-thermal pulsed electric fields to the duodenum to treat type 2 diabetes. Breakthrough-designated and in a randomized, sham-controlled IDE study.

San Diego, CA  ·  Est. 2015  ·  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.

London, UK  ·  Est. 2019  ·  Series B  ·  $68M raised  ·  In development

Developing a wearable microsensor that continuously measures molecules just beneath the skin, starting with glucose. Its filament is roughly a tenth the length of a conventional CGM's.

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.

Mountain View, CA  ·  Seed  ·  $18M raised  ·  510(k) cleared

UpDoc makes prescription software that collects diabetes data from patients through a voice and chat agent. It issues insulin dosing instructions within parameters set by the prescriber.

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