Dexcom (Nadsaq:DXCM) has received FDA clearance for its Stelo over-the-counter (OTC) continuous glucose monitor (CGM) for children. The FDA said in a news release that it cleared Stelo for people two years of age and older who do not use insulin. It became the first OTC CGM system granted clearance in March 2024, initially getting […]
Pediatrics
MannKind earns FDA nod for on-body infusor, new autoinjector patents
MannKind (Nasdaq:MNKD) announced today that the FDA approved its Furoscix (furosemide) on-body infusor for pediatric patients. The company also received additional IP protection for its investigational Furoscix ReadyFlow autoinjector. ReadyFlow remains under FDA review after the agency accepted a supplemental New Drug Application (sNDA) earlier this month. For the on-body infusor, the FDA approved the […]
Medtronic MiniMed 780G wins CE mark for type 2 diabetes, young children
Medtronic (NYSE:MDT) announced today that it received CE mark to expand its MiniMed 780G’s indications, including for type 2 diabetes. The expansion brings the automated insulin delivery (AID) system to individuals aged 2 years and older with type 1 diabetes. It also enables the use of MiniMed 780G during pregnancy and by those with type […]
Data backs Medtronic MiniMed 780G for type 2, children as company seeks expanded indications
Medtronic (NYSE:MDT) today shared data supporting the use of its MiniMed 780G automated insulin delivery system in a range of patients. The medtech giant highlighted improved glycemic outcomes for those with type 2 diabetes and in young children. Investigators shared data at the American Diabetes Association’s 85th Scientific Sessions in Chicago. In one study, participants […]
Aerosol drug delivery company Aerogen to expand in Ireland
Aerogen announced today that it plans to invest about $308.5 million (€300 million) to expand operations in Ireland. The company — headquartered in Dangan, Galway — expects its investment to create 725 new jobs in Ireland over the next 10 years. According to Enterprise Ireland, the aerosol drug delivery company is Ireland’s largest indigenous medtech […]
NIH launches effort to combat type 2 diabetes in young people
The National Institutes of Health (NIH) launched a nationwide consortium to address the rise in youth diagnosed with type 2 diabetes. According to a press release, NIH expects that trend — which it observed over the past two decades — to continue moving forward. It aims to advance understanding of the biologic, social, and environmental […]
The biggest stories from the American Diabetes Association (ADA) 2023 Scientific Sessions
As it does every year, this past week, the American Diabetes Association convened its Scientific Sessions to bring together leaders in the diabetes space. At last year’s event, next-generation technologies from the big hitters took the spotlight. The 83rd iteration this past week produced a range of new studies, product updates and positive news for […]
Senseonics announces first pediatric 365-day CGM insertion
Senseonics (NYSE:SENS) announced that the first pediatric study participant received an Eversense 365-day CGM insertion. The insertion took place as part of the company’s ENHANCE clinical trial at the AMCR Institute. AMCR, a clinical research center, focuses on pre-diabetes, type 1, type 2 diabetes and obesity. The study operates under the direction of Dr. Timothy […]
Study backs Tandem Control-IQ artificial pancreas in young children
Tandem Diabetes Care (Nasdaq:TNDM) announced positive study data for its artificial pancreas using Control-IQ technology. The study demonstrated improved blood sugar control in children ages 2-6 with type 1 diabetes. It evaluated an artificial pancreas using the Tandem t:slim x2 insulin pump with Control-IQ technology. Results were published in the New England Journal of Medicine. […]
Akili lays off 46 workers
Akili announced that its board of directors approved an operating plan for 2023 that includes a 30% workforce reduction. The Boston-based digital therapeutic developer’s reduction reaches across different areas and functions. In total, 30% of Akili’s workforce amounts to 46 employees. The company communicated the decision to employees on Jan. 12 and expects to complete […]
