DreaMed Diabetes AI announced today that it received FDA clearance that expands its platform’s target population to cover type 1 and type 2 diabetes. Tel Aviv, Israel-based DreaMed’s Advisor Pro AI clinical decision support system assists healthcare providers in the management of diabetes patients who use insulin pumps or injections and monitor their glucose using […]
BREAKING: Medtronic expands Class I recall of MiniMed 600 series insulin pumps
The FDA today announced that Medtronic (NYSE:MDT) has expanded the Class I recall of its MiniMed 600 series insulin pumps. Medtronic today notified customers by email and phone that the recall has been expanded to replace all MiniMed 600 series insulin pumps that contain the clear container ring. The Fridley, Minnesota-based company first warned of […]
Stevanato Group is constructing a new facility in Indiana
Stevanato Group (NYSE:STVN) announced today that it will begin construction on a new U.S. facility in Fishers, Indiana. Piombino Dese, Italy-based Stevanato Group will begin construction on the new facility this month with expectations for the site to be operational in 2023. According to a news release, constructing the new facility falls in line with […]
Insulet reports positive study results for Omnipod 5
Insulet (NSDQ:PODD) last week presented positive pivotal trial data for its Omnipod 5 automated insulin delivery system. Acton, Massachusetts-based Insulet’s Omnipod 5 — which it touts as the world’s first tubeless wearable system for continuously adapting insulin delivery based on glucose levels and trends — significantly improved time in range and reduced HbA1c in the […]
MedAlliance completes trial enrollment for sirolimus-eluting balloon for treating PAD
MedAlliance announced today that it completed patient enrollment for a trial of its Selution SLR sirolimus drug-eluting balloon. Geneva, Switzerland-based MedAlliance, along with Japanese partner MDK Medical, completed the enrollment following the acceptance of a Clinical Trial Notification (CTN) by the Pharmaceutical Products and Medical Devices Agency (PMDA) of Japan in June 2020. The study […]
Thermo Fisher authorizes $3B in share repurchases
Thermo Fisher Scientific (NYSE:TMO) yesterday announced authorization for the repurchase of $3 billion in common stock shares. Waltham, Massachusetts-based Thermo Fisher’s board of directors approved the repurchase of $3 billion in shares of its common stock in the open market or in negotiated transactions, according to a news release. The authorization has no expiration date […]
FDA approves Baxter’s norepinephrine injection for treating low blood pressure
Baxter (NYSE:BAX) announced today that it received FDA approval for its premix norepinephrine bitartrate in 5% dextrose injection. Deerfield, Illinois-based Baxter launched the norepinephrine injection following the approval for raising blood pressure in adult patients with severe, acute hypotension (low blood pressure). According to a news release, the company’s formulation of norepinephrine is the first […]
BD says glass prefillable syringes still perform after deep cold storage
BD (NYSE:BDX) today shared the results from a preliminary study investigating the impact of deep cold storage on glass prefillable syringes. Franklin Lakes, N.J.-based BD’s study evaluated deep cold storage (-20°C and -40°C) as traditional vaccine formulations are commonly stored up to about 2°C to 8°C, while mRNA vaccine formulations (the type of COVID-19 vaccine […]
Welldoc wins expanded FDA clearance for BlueStar insulin dosing platform
Welldoc announced today that it received another FDA 510(k) clearance for its BlueStar diabetes treatment platform. Columbia, Maryland-based Welldoc’s new clearance for BlueStar — the ninth in total — expands insulin dosing support to most types of insulin, including bolus and premixed insulin titration for type 2 diabetes. Previous FDA clearances include in June 2020 […]
IVX Health raises $100M to accelerate expansion for infusion centers
IVX Health announced today that it completed a $100 million Series F minority investment round from Great Hill Partners. Nashville, Tennessee-based IVX plans to utilize the funding to accelerate its entry into new markets in 2022 and beyond in its effort to make its outpatient infusion centers the country’s preferred destination for pharmaceutical care for […]
