Medtronic plc’s diabetes unit posted another win with the U.S. FDA approval of the Simplera continuous glucose monitoring sensor for use with the Minimed 780G pump system, helping the company catch up with competitors Abbott Laboratories and Dexcom Inc. Medtronic plans to begin a limited launch of the Simplera Sync in the U.S. this fall.
The battle to claim the continuous glucose monitor with the longest wear time continues with Dexcom Inc.’s G7 15 Day continuous glucose monitor gaining U.S. FDA clearance on April 10 for adults with diabetes. The company said it now takes the lead with the 15-day duration, but Abbott Laboratories also offers 15 days of useful life for its Freestyle Libre 3 plus.
The first patent from Palo Alto, Calif.-headquartered Updoc Inc. provides protection for their development of an artificially intelligent, voice-based method for prescribing, managing and administering at least one medication for management of type 2 diabetes to a patient.
The U.S. FDA’s March 4, 2025, warning letter to Dexcom Inc. is a well-detailed but heavily redacted document explaining the agency’s misgivings about procedures such as monitoring of acetaminophen content in glucose test dishes.
Vicentra BV aims to make its Kaleido 2 insulin patch pump and automated insulin delivery system even smaller than its current device, already amongst the smallest, lightest and most precise insulin device on the market, new CEO Tom Arnold told BioWorld. As the company works to meet growing demand for its product, Kaleido has the potential to transform diabetes care, he said.
Tandem Diabetes Care Inc.’s Control-IQ+ automated insulin delivery system improved multiple measures of glycemic control in individuals with type 2 diabetes who use insulin, a study presented March 19 at the 18th International Conference on Advanced Technologies & Treatments for Diabetes and published in The New England Journal of Medicine demonstrated.
The Vivani Medical Inc. combination appears to be over less than three years since its inception after the company reported plans to spin off Cortigent, the division that develops brain implants.
Tandem Diabetes Care Inc. reported that its next-generation automated insulin delivery algorithm, Control-IQ+ technology (Control-IQ+), is cleared by the U.S. FDA for use by people with type 2 diabetes (T2D) ages 18 and older.
Beta Bionics Inc. kicked off the new year with plans for an initial public offering of 7.5 million shares “as soon as practicable.” Expected to be priced at $14 to $16 per share, the IPO would gross $105 million to $120 million for the insulin delivery device maker.
Glooko Inc. and Hedia ApS launched an integrated software solution in the U.K. to support people with diabetes who require advanced doses of bolus insulin. The solution combines Glooko’s diabetes monitoring platform with Hedia’s diabetes dosing recommendation app to deliver personalized insulin dosing advice to people with type 1 and type 2 diabetes.