Elutia (Nasdaq:ELUT) announced the first-ever patient implant of its EluPro drug-eluting biologic envelope cleared by the FDA. Dr. John Catanzaro of the East Carolina University Health Medical Center in Greenville, North Carolina, performed the first procedure. Elutia says this marks the first implant of the world’s first antibiotic-eluting biologic envelope. Elutia designed EluPro to prevent […]
Drug-Device Combinations
Eli Lilly has positive once-weekly insulin data
Eli Lilly (NYSE:LLY) today announced positive results from phase 3 clinical trials evaluating its once-weekly insulin efsitora alfa. The Indianapolis-based pharmaceutical giant evaluated its once-weekly insulin in insulin-naïve adults in the QWINT-1 study. These adults have type 2 diabetes and are using basal insulin for the first time. Additionally, Eli Lilly’s QWINT-3 trial looked at […]
Smiths Medical warns on infusion cassette reservoirs in Europe
ICU Medical’s Smiths Medical unit issued an urgent field safety notice in Europe to warn of issues with certain medication cassette reservoirs. Smiths Medical’s warning pertains to specific models and lots of its 50 mL and 100 mL CADD medication cassette reservoirs. Certain reservoirs may exhibit a weakened weld joint between the medication bag and […]
Beta Bionics to pair bionic pancreas with Abbott FreeStyle Libre 3 Plus
The companies plan to combine Abbott’s FreeStyle Libre 3 Plus continuous glucose monitor (CGM) with the Beta Bionics iLet bionic pancreas. According to Beta Bionics, this will make iLet the first available AID system to integrate with Libre 3 Plus in the U.S. The companies plan to launch this integration in the fourth quarter of […]
Embecta wins FDA clearance for disposable insulin patch pump
Embecta (Nasdaq:EMBC) announced today that it received FDA 510(k) clearance for its proprietary disposable insulin delivery system. The open-loop system is indicated for adults who require insulin to manage diabetes, including both type 1 and type 2 diabetes. It features a tubeless design with a 300-unit insulin reservoir, informed by feedback from people with type […]
Glytec, Roche expand diabetes management collaboration
Glytec announced today that it expanded its collaboration with Roche to integrate software with smart diabetes technology. The two companies initially struck a partnership in early 2022. They aimed to combine Glytec’s FDA-cleared Glucommander insulin dosing decision support software with Roche’s expertise in medical devices and IT solutions. It marked an effort to address the […]
FDA clears Insulet Omnipod 5 for people with type 2 diabetes
Insulet (Nasdaq:PODD) announced today that the FDA cleared its Omnipod 5 automated insulin delivery for use by people with type 2 diabetes. Clearance makes Omnipod 5, the company’s latest-generation AID system, the first and only such system cleared for type 1 and type 2 diabetes. Its indication covers those ages 18 and older in the […]
Dexcom launches Stelo over-the-counter CGM
Dexcom (Nasdaq:DXCM) announced today that it launched its Stelo over-the-counter (OTC) continuous glucose monitor (CGM) biosensor. The San Diego-based company made Stelo available for purchase — without prescription — at Stelo.com. Dexcom became the first company to receive FDA clearance for an OTC CGM when the FDA cleared Stelo in March. Abbott followed in June […]
Abbott grants $1.6M to ADA in new diabetes collaboration
Abbott (NYSE:ABT) and the American Diabetes Association (ADA) announced a collaboration to support people with diabetes, obesity and metabolic dysfunction. Through the collaboration, ADA plans to review and consolidate evidence to help healthcare professionals understand the unique nutritional needs associated with diabetes, obesity and metabolic dysfunction. ADA also intends to assess the role nutrition formulas […]
Former Medtronic acquisition target EOFlow to raise $61.5M, faces Insulet patent infringement lawsuit
EOFlow faces a patent infringement lawsuit from fellow insulin patch pump maker Insulet as it attempts to bring in millions in a new funding round. The Korea-based company develops the EOPatch — a tubeless, wearable and fully disposable insulin delivery device. EOFlow was at one point set to be acquired by Medtronic for $738 million last […]
