Embecta (Nasdaq:EMBC) today revealed its phased plan to create value and shift priorities toward broader medical applications. The pure-play diabetes technology company has endured ups and downs since its 2022 spin-off from BD. That includes an FDA approval for a disposable insulin patch pump system in September 2024, only to be followed by the discontinuation […]
Medtronic earns expanded CE mark for Prevail paclitaxel-coated balloon
Medtronic announced today that it received CE mark for several expanded indications for its Prevail balloon catheter. The expanded indications for the paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter (or drug-coated balloon/DCB) cover the treatment of coronary artery disease (CAD). According to the medtech giant, Prevail now has the broadest range of CE mark […]
Sequel Med Tech to pair automated insulin delivery system with Abbott’s future dual glucose-ketone sensor
Sequel Med Tech announced today that it agreed to integrate its twiist automated insulin delivery system with a future Abbott sensor. The companies agreed to pair twiist, powered by Tidepool, with Abbott‘s glucose-ketone sensor, currently under development. Sequel said the agreement aims to improve outcomes for people with type 1 diabetes. It adds ketone sensing capabilities […]
Medtronic to separate Diabetes business unit
Medtronic (NYSE:MDT) announced today that it intends to separate its Diabetes business into a new standalone company. The medtech giant said the strategic decision can create “a more focused Medtronic” with a more simplified portfolio in high-margin growth markets. At the same time, it creates an independent, scaled leader in diabetes. The new company — […]
Tandem Diabetes Care wins CE mark for Mobi insulin pump with Control-IQ+ technology
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 […]