BD [WtwhTicker symbol=”BDX”](NYSE: BDX)[/WtwhTicker] issued an urgent field safety notice in the UK to warn of potential issues with its Alaris neXus V700 infusion pump system. According to the notice, BD identified that the anti-free flow clamp may not activate when the system door opens. This allows for the potential uncontrolled flow of medication. The […]
Drug-Device Combinations
FDA says InfuTronix infusion pump recall includes 1 death
The FDA today shared new information on an infusion pump recall from InfuTronix that included one report of death. Following a voluntary removal, the FDA deemed the recall Class I, the most serious kind, earlier this month. It affects 52,328 devices in the U.S. in total. Today, the agency shared that a slew of issues […]
ICU Medical’s Smiths Medical is reportedly closing a New Hampshire plant, cutting 220 jobs
ICU Medical’s Smiths Medical unit reportedly plans to close a New Hampshire manufacturing facility that houses about 220 employees. The infusion technology maker plans to close the plant in Keene, New Hampshire, next year, according to the Keene Sentinel. The outlet said VP of Global Marketing, Tom McCall, confirmed the decision to close today after […]
Study highlights benefits of automated insulin delivery for children in UK
A study in the UK demonstrated significant improvements in HbA1c for users of automated insulin delivery technologies. This comes on the heels of a UK NHS initiative to provide tens of thousands of children and adults with type 1 diabetes in the country with an artificial pancreas. The study aimed to assess the efficacy of […]
Non-insulin, basal CGM use exceeds analysts’ expectations, Dexcom and Abbott to benefit
William Blair analyst Margaret Kaczor reported surprise at the increase in users of CGM within the non-insulin and basal insulin populations. Kaczor expects Dexcom and Abbott to benefit from the trend with their next-generation CGM offerings after meetings with both companies’ management. Both companies launched next-gen CGMs in recent years (Dexcom G7 and Abbott FreeStyle […]
Concept Medical enrolls first patient in drug-coated balloon study
Concept Medical announced today that it commenced the FDA investigational device exemption (IDE) study of its MagicTouch system. MagicTouch, a sirolimus drug-coated balloon (DCB), treats in-stent restenosis (ISR) in coronary artery disease (CAD). Dr. Said Ashraf enrolled the first patient in the MAGICAL-ISR study at the AtlantiCare Institute in Atlantic City, New Jersey. The balloon […]
Kindeva Drug Delivery has a new COO
Kindeva Drug Delivery announced today that it appointed Denis Johnson as its new chief operating officer (COO). Johnson’s responsibilities include leading global operations for Kindeva’s manufacturing and R&D facilities across the U.S. and UK. The company expects him to facilitate the expansion and opening of the company’s new aseptic injectable fill-finish site in Bridgeton, Missouri. […]
Fresenius Kabi has a Class I recall of Ivenix Infusion System software
The FDA this week labeled Fresenius Kabi’s recall of some Ivenix Infusion Systems (IIS) as Class I, the most serious kind. Fresenius Kabi USA issued the recall of Ivenix Infusion System LVP software, its infusion pump software, due to an issue of multiple software anomalies occurring that can potentially result in serious patient harm or […]
Ypsomed, ten23 health collab on YpsoDose patch injector
Ypsomed announced today that it entered into a partnership with ten23 health to commercialize its YpsoDose wearable injector. Burgdorf, Switzerland-based Ypsomed designed YpsoDose for the subcutaneous self-injection of large-volume doses. ten23 health, a Swiss CDMO, offers drug development, filling and device assembly expertise to contribute to the product offering. The strategic collaboration sees both parties […]
RenovoRx raises $11.1M to support oncology drug delivery trial
RenovoRx (Nasdaq:RNXT) announced today that it closed a private placement worth gross proceeds of approximately $11.1 million. The $11.1 million adds to a separate private placement that brought in proceeds of approximately $6.1 million in January. RenovoRx plans to use the funds to strengthen its balance sheet and extend its cash runway into 2026. Funds […]