The U.K. National Institute for Health and Care Excellence (NICE) has seen the nation’s spending numbers for diabetes, which is said to account for roughly 10% of healthcare spending in the U.K., and responded in a collaboration with the National Health Service (NHS).
Sibionics Technology Co. Ltd. said it received the CE mark for its continuous glucose monitoring (CGM) system, coined the Sibionics GS1 CGM, helping the company expand its market opportunities beyond China.
Zense-Life Inc. reported seeking patent protection for systems and processes for manufacturing working wires for a continuous biological sensor, that reduce cost and improve accuracy and efficiency compared to current technique.
An artificial intelligence (AI) algorithm using voice technology developed by Klick Inc. could be a game changer for diagnosis of type 2 diabetes, helping to identify the 50% of individuals who unknowingly have the disease. The technology uses a six- to 10-second voice clip spoken into a smartphone plus basic health data to detect diabetes in close to nine out of 10 individuals, a study published in Mayo Clinic Proceedings: Digital Health found.
Dexcom Inc. revealed new clinical data at the European Association for the Study of Diabetes (EASD) which highlighted the benefits of the use of continuous glucose monitoring (CGM). Results from the COMISAIR seven-year study, the longest prospective real-world CGM trial ever conducted, showed significant and continued reduction of HbA1c with the use of real-time CGM by people with type 1 diabetes.
Following the receipt of a U.K. Conformity Assessed (UKCA) mark for its kidney function diagnostic software, the CKD Screening Prioritizer (CSP), Gendius Ltd. is hoping to soon receive CE mark and then U.S. FDA approval next year. Given that people with type 2 diabetes are at a higher risk of developing chronic kidney disease, Gendius’ pre-screening software will be “transformative” for patients and health care systems, CEO Rory Cameron told BioWorld in an interview.
In another boost to its diabetes portfolio, Medtronic plc was granted CE mark approval for its Simplera continuous glucose monitor (CGM) sensor. The EU greenlight for Simplera follows the U.S. FDA approval for Medronic’s Minimed 780G insulin pump system earlier in the year. Simplera is an all-in-one disposable CGM sensor which features a two-step insertion process and will help patients who must have multiple daily injections (MDI) manage their diabetes.
Safety concerns overrode benefit when the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously, 19-0, Sept. 21 that the potential risks of Intarcia Therapeutics’ ITCA-650 outweighed the compliance and A1C-lowering benefits the twice-yearly implantable exenatide-device combination product could provide for adults with type 2 diabetes.
Aiming to provide additional utility and information to its continuous glucose monitors (CGMs), Dexcom Inc. is tying in the nutrition information provided by Rxfood Corp.’s app for customers in Canada. Clinics, hospitals, pharmacies, health plans, employers and others can make the app available to the beneficiaries and patients who use the Dexcom G6 or G7 systems, once the program is rolled out.
A Sept. 21 U.S. FDA advisory committee meeting will either be a “Hail Mary” or a last gasp of life for ITCA-650, a twice-yearly implantable exenatide-device combination product intended to improve glycemic control in adults with type 2 diabetes.
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