Dexcom (Nasdaq:DXCM) announced today that its G6 CGM is being worn by astronauts as part of the Polaris Dawn mission. Polaris Dawn launched this morning with astronauts wearing the G6 to better understand the effects of spaceflight on human health. The crew intends to conduct research to advance human health on Earth and the understanding […]
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Elutia announces first implant of drug-eluting bioenvelope for pacemakers and neurostimulators
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 […]
Abbott launches Lingo over-the-counter CGM biosensor in the U.S.
Abbott (NYSE:ABT) announced today that it made its Lingo continuous glucose monitoring system available without a prescription in the U.S. The technology is now available in the U.S. at hellolingo.com, as well as in the United Kingdom. Lingo features a biosensor and mobile app designed for customers who want to improve their overall health and […]
Beta Bionics to pair bionic pancreas with Abbott FreeStyle Libre 3 Plus
Beta Bionics announced that it partnered with Abbott (NYSE:ABT) to integrate the company’s CGM with its automated insulin delivery system. 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 […]
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 […]
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 […]
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 […]
The 9 largest diabetes technology companies in the world
Diabetes technology comes in all shapes and sizes: insulin delivery systems, continuous glucose monitors and more. The companies that develop these technologies come in all shapes and sizes, too. Some focus entirely (or almost entirely) on solutions for people with diabetes. Others are much larger medtech firms that still have sizable business units that focus […]
ICU Medical recalls some infusion pump batteries, updates instructions
The FDA issued a notice to warn of a recall of ICU Medical (Nasdaq:ICUI) Plum 360 infusion pump system batteries due to a manufacturing defect. ICU Medical designed its Plum 360, Plum A+ and Plum A+3 systems for large-volume fluid infusion. The system delivers blood or blood products, drugs and other fluid mixtures through subcutaneous, […]