Insulet (Nasdaq:PODD) today announced the full market release of the Omnipod 5 automated insulin delivery app for iPhone in the U.S. Acton, Massachusetts-based Insulet now offers the app for free download from the Apple App Store. It allows users to fully control their Omnipod 5 patch pump from their compatible iPhone. For example, users can […]
Drug-Device Combinations
Elixir Medical has positive data for drug-eluting bioadaptive implant
Elixir Medical announced positive data demonstrating the benefit of its DynamX coronary bioadaptor system in target lesion failure (TLF). Data highlighted the success of DynamX compared to Medtronic’s Resolute Onyx zotarolimus drug-eluting stent (DES). The study looked at complex patient populations within the INFINITY-SWEDEHEART randomized controlled trial. Data included an analysis of patients with acute […]
Insulcloud wins FDA nod to bring smart insulin pen cap tech to U.S.
Insulcloud today announced its strategic expansion into the U.S. following FDA clearance for its Insulclock CAP smart device. Madrid, Spain-based Insulcloud designed the device to monitor patient use of disposable insulin pens in real-time, increasing therapy adherence. The company said in a news release that the U.S. expansion underscores Insulclock CAP’s safety, efficacy and quality. […]
Tidepool, Abbott collab on data integration for FreeStyle Libre
Tidepool today announced a new data integration with Abbott for the company’s FreeStyle Libre continuous glucose monitors (CGMs). The companies aim to deliver cloud-to-cloud integration for an automatic stream of data from patients using Abbott’s CGMs in the U.S. Data streams to Tidepool+, a diabetes data visualization and population health platform. Tidepool+ provides intuitive tracking […]
Senseonics announces $16M registered direct offering
Senseonics (NYSE:SENS) announced today that it entered into a definitive agreement to offer $16 million in common stock. Germantown, Maryland-based Senseonics plans to offer more than 45.7 million shares of common stock. It priced the shares at 35¢ per share in a registered direct offering. In a concurrent private placement, the company agreed to issue […]
Dexcom submits 15-day CGM to FDA, beats Street in Q3
Dexcom (Nasdaq:DXCM) announced that, following the conclusion of the third quarter, it submitted its 15-day G7 CGM to the FDA. G7, the company’s latest-generation continuous glucose monitor (CGM), presently has approval for a 10-day wear time. Shares of DXCM were up slightly at the opening of trading today. Yesterday evening, Dexcom also reported third-quarter results […]
Ypsomed, BD collab on self-injection systems for high-viscosity biologics
BD (NYSE:BDX) and Ypsomed today announced a strategic collaboration to advance self-injection solutions for high-viscosity biologic drugs. In a joint project, the companies pre-assessed and streamlined the integration of the BD Neopak XtraFlow glass prefillable syringe with the Ypsomed YpsoMate 2.25 auto-injector platform. They aim to address current limitations by enabling the delivery of higher-viscosity […]
Luna Diabetes launches trial for ‘world’s smallest insulin patch pump’
Luna Diabetes announced that it launched its pivotal trial for Luna, the company’s miniature automated insulin delivery system. The company describes the system — designed to transform nighttime glucose management — as the world’s smallest patch pump. Luna delivers micro-doses of insulin while the user sleeps. According to the company, it offers the “simplest onboarding […]
FDA approves IDE for Medtronic Prevail drug-coated balloon
Medtronic (NYSE: MDT) announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB). The medtech giant can now begin a pivotal clinical trial for the coronary paclitaxel DCB for in-stent restenosis (ISR) and de novo small vessel disease. It plans to use data from its Prevail Global Clinical Program […]
ViCentra wins CE mark for Kaleido insulin pump
ViCentra announced that it received CE mark approval for its Kaleido insulin pump under European Medical Device Regulation (EU MDR). Utrecht, The Netherlands-based ViCentra aims to deliver high-quality, user-friendly solutions for people with diabetes. The system last year launched in a hybrid closed-loop automated insulin delivery system that uses the Dexcom G6 CGM. Kaleido features pulse […]
