Tandem Diabetes Care (Nasdaq:TNDM) filed an SEC Form 8-K to state that it received CE mark for its Mobi insulin delivery system. San Diego-based Tandem can now market the miniature, durable automated insulin delivery system with Control-IQ+ technology in Europe. According to the filing, the company intends to pursue additional regulatory and pre-commercial activities now. […]
Glooko adds chief strategy officer to chief medical officer’s title
Glooko announced today that it expanded the position of Dr. Mark Clements to make him its chief medical and strategy officer. Clements became the Palo Alto, California-based diabetes management company’s fractional chief medical officer in 2016. He now steps into an expanded, full-time role designed to integrate Glooko’s clinical vision, product roadmap and data solutions. […]
Cordis launches 10,000-patient registry for drug-eluting balloon
Cordis today announced the initiation of a global registry to track real-world outcomes for the Selution SLR drug-eluting balloon (DEB). Miami Lakes, Florida-based Cordis expects the SELUTION Global Coronary Registry to enroll up to 10,000 patients worldwide. It says that would make it one of the largest coronary DEB registries to date. Investigators plan to […]
Senseonics opens $50M public offering, $25M private placement with Abbott
Senseonics (NYSE:SENS) announced today that it commenced an underwritten public offering of common stock worth $50 million. The long-term implantable continuous glucose monitor (CGM) maker expects to grant underwriters a 30-day option to purchase up to an additional 15% of the total number of shares of stock offered in the public offering. All shares to be […]
Study links Abbott CGM use to lower risk of hospitalizations due to heart complications
Abbott (NYSE:ABT) today announced results from real-world studies demonstrating benefits with its FreeStyle Libre continuous glucose monitoring (CGM) technology. Results from the REFLECT studies show that Libre CGM is associated with a significant reduction in the risk of hospitalization for heart complications in people with diabetes. Data demonstrated that CGM can help lessen the severity […]
Go-Pen ApS wins FDA nod for user-filled insulin pen
Go-Pen ApS announced recently that it received FDA 510(k) clearance for its Go-Pen cost-effective, user-filled insulin pen. Copenhagen, Denmark-based Go-Pen ApS says that, despite advances in diabetes technology, approximately one-third of insulin users worldwide (more than 20 million people) rely on traditional vials and syringes due to cost and access limitations. According to a news […]
BD files patent infringement lawsuit against Baxter over infusion pump tech
BD (NYSE:BDX) filed a lawsuit in a U.S. District Court alleging patent infringement by Baxter (NYSE:BAX) related to infusion pump technology. The company filed its complaint in the U.S. District Court for the District of Delaware on May 12, 2025. BD’s complaint singles out six specific patents: the “180,” “058,” “880,” “868,” “414,” and “703” […]
Tandem Diabetes Care subsidiary earns new FDA clearance for insulin infusion set
Tandem Diabetes Care (Nasdaq:TNDM) shared in an SEC filing that its Capillary Biomedical (CapBio) subsidiary won FDA 510(k) clearance for a new infusion set. The company won clearance for its SteadiSet Infusion Set, according to an SEC Form 8-K. It’s a wearable infusion set that delivers insulin from an insulin pump to the body. San Diego-based […]
Glucotrack can proceed with long-term glucose monitor study in Australia
Glucotrack (Nasdaq:GCTK) announced today that it received a hospital’s ethical approval to study its continuous blood glucose monitor (CBGM). The St. Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) gave the nod for a long-term clinical study. It plans to include participants with both type 1 and type 2 diabetes using the CBGM. Rutherford, New […]
Dexcom promotes Jake Leach to president role
Dexcom (Nasdaq:DXCM) announced today that it promoted Jake Leach to the role of president, in addition to his post as COO. Leach originally took over as COO in 2022. He previously served as chief technology officer (CTO), starting in 2018. In that role, he led the company’s research, product development, product management and engineering departments. […]
