Glooko announced today that it secured $100 million in a financing round and appointed Mike Alvarez as its new CEO. Russ Johannesson said on LinkedIn that he stepped down from the CEO post at Glooko. He held the corner office for six-and-a-half years as Alvarez now takes over. Alvarez brings more than two decades of […]
Technology
Trinity Biotech completes pre-pivotal study of next-gen CGM
Trinity Biotech today announced that it completed the first pre-pivotal clinical trial in Europe for its next-generation CGM technology. The study assessed the analytical performance of continuous glucose monitoring (CGM) technology enhancements implemented by Trinity. Dublin, Ireland-based Trinity added the improvements to the CGM technology it acquired from Waveform Technologies in January. Trinity implemented an […]
BD partners with ten23 health on prefilled syringe manufacturing
BD (NYSE:BDX) announced today that it entered into a collaboration with ten23 health to develop a new way to track prefillable syringes (PFS). ten23 health, a Swiss CDMO, offers drug development, filling and device assembly expertise to contribute to the product offering. It recently entered into a production collaboration with on-body drug delivery device maker […]
Medtronic recalls some MiniMed automated insulin delivery systems with battery issues
Medtronic (NYSE:MDT) today announced a voluntary recall warning of battery issues with its MiniMed 600 and 700 series insulin pumps. FDA deemed the recall Class I, the most serious kind. The medtech giant issued a field action starting on July 31, notifying customers to follow built-in alerts for battery status. Customers should contact Medtronic if […]
Senseonics, Ascensia launch Eversense 365 year-long CGM in the U.S.
Ascensia Diabetes Care announced today that it launched the Eversense 365 CGM system from Senseonics (NYSE:SENS) in the U.S. Eversense 365, an implantable continuous glucose monitor (CGM), is indicated for people with type 1 and type 2 diabetes aged 18 years and older. Senseonics announced last month that it received FDA clearance for Eversense 365. With […]
Stevanato Group expands large-volume drug delivery offerings
Stevanato Group announced today that it expanded the capacity of its Vertiva on-body device for subcutaneous large-volume drug delivery. The Italy-based company says its Vertiva platform now covers 10mL volumes. It plans to present the latest Vertiva development at CPhI Milan next month. Vertiva features a single-use injection unit (or pod) and a multi-use smart […]
Dexcom, Retta, Beyond Type 2 team up to raise glucose awareness
Dexcom (Nasdaq:DXCM) today announced a collaboration to establish National Glucose Awareness Week from Sept. 23-29, 2024. The San Diego-based continuous glucose monitor (CGM) maker aims to close the glucose knowledge gap. In partnership with the nonprofit Beyond Type 2, Dexcom wants to encourage people to take action “to own their glucose health.” According to a […]
Ypsomed reports positive outcomes with automated insulin delivery for maternal health
Ypsomed reports positive outcomes from a large, randomized trial of its closed-loop insulin delivery technology during type 1 diabetes pregnancy. The Switzerland-based company’s AiDAPT study demonstrated that hybrid closed-loop therapy significantly improves maternal glycemic control. Pregnant women with type 1 diabetes used the automated insulin delivery system based on the CamDiab CamAPS FX algorithm in […]
Fresenius Kabi recalls and removes some Ivenix infusion pump administration sets from market
The FDA issued a notice outlining a serious recall of Ivenix infusion pump administration sets from Fresenius Kabi. This recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type as it may cause serious injury or death. Fresenius Kabi recalled certain lots of the […]
Tandem wins clearance for t:slim X2 pump with Eli Lilly fast-acting insulin in Europe
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it received clearance for the use of rapid-acting insulin with its t:slim X2 pump. The company can now offer its automated insulin delivery (AID) system with Eli Lilly’s Lyumjev (insulin lispro-aabc injection) ultra-rapid-acting insulin in Europe. Previously, the t:slim X2 pump had clearance for use with Humalog and […]