BD (NYSE:BDX) announced that it reached an agreement with the SEC to resolve an investigation related to its Alaris system. The investigation relates to prior public disclosures and SEC reporting regarding Alaris, an infusion pump system. BD neither admits nor denies the findings of an SEC order related to those matters occurring more than four years […]
MannKind reports positive data for inhaled insulin for children
MannKind today announced six-month results from its Phase 3 INHALE-1 study of Afrezza insulin inhalation powder in children. INHALE-1 looked at Afrezza in children and adolescents between 4-17 years of age. The company expects the data to support an upcoming request for a supplemental new drug application (sNDA) meeting with the FDA. It aims to […]
European court rules in favor of Abbott in Dexcom CGM patent spat
The Unified Patent Court in Paris sided with Abbott (NYSE:ABT) following a CGM patent infringement claim from Dexcom (Nasdaq:DXCM). Abbott and Dexcom are two leaders in the continuous glucose monitoring (CGM) space. They offer market-leading platforms, with Abbott’s FreeStyle Libre 3 and Dexcom’s G7 representing their latest-generation technologies. Dexcom requested that the court find infringement […]
Fresenius Kabi warns on Ivenix infusion pump valves
The FDA said Fresenius Kabi told customers to remove its Ivenix large-volume infusion pumps from use for repair. This warning from the FDA comes as part of its Communications Pilot to Enhance the Medical Device Recall Program. The agency became aware of a potentially high-risk device issue and plans to keep the public informed on […]
Qnovia raises $16M to support nicotine inhaler for smoking cessation therapy
Qnovia announced that it raised $16 million in Series B funding to support its inhaled smoking cessation therapy platform. Blue Ledge Capital, Evolution VC Partners, Vice Ventures and Gaingels led the financing. It brings Richmond, Virginia-based Qnovia to $50 million raised since inception. Funds raised by Qnovia support its proprietary inhaled drug delivery platform, the […]
Tandem makes t:slim X2 insulin pump available with Dexcom G7 in Canada
Tandem Diabetes Care (Nasdaq:TNDM) announced today that t:slim X2 insulin pump users in Canada can now access full compatibility with Dexcom (Nasdaq:DXCM) CGMs. Following authorization from Health Canada, in-warranty pump users can access full compatibility with the G7 and G6 CGMs. This makes t:slim X2 the first and only pump integrated with both continuous glucose […]
Senseonics highlights early success with Eversense 365 launch
Senseonics (NYSE:SENS) today announced significant progress with the launch of its Eversense 365 continuous glucose monitor (CGM). In September, the company won FDA clearance for the Eversense 365 one-year implantable CGM. With the clearance, it became the world’s first 365-day CGM system. Senseonics and its global distribution partner, Ascensia Diabetes Care, announced the launch for Eversense 365 […]
NuGen launches needle-free insulin delivery device in Canada
NuGen Medical Devices announced recently that it launched its InsuJet needle-free insulin delivery device in Canada. The company initiated its launch on Nov. 15 — the day after World Diabetes Day. It received an initial order for 2,500, then a second order for 750 units of InsuJet starter kits and consumables. That represents revenue of […]
Cardinal Health recalls certain insulin syringe component packs
The FDA deemed a recall of Cardinal Health (NYSE:CAH) insulin syringe luer lock packs as type I, the most serious kind of recall. This recall relates to the company’s Monoject U-100 mL insulin syringe luer lock with tip cap soft pack (extended conical tip). The device is used to administer insulin under the skin (subcutaneous) or […]
Insulet prevails in IP battle with patch pump maker EOFlow
Insulet (Nasdaq:PODD) announced that it successfully defended its intellectual property against EOFlow in U.S. federal court. Both companies develop automated insulin delivery systems utilizing patch pump technology. Insulet offers the market-leading Omnipod platform, while Korea-based EOFlow develops the EOPatch — similarly, a tubeless, wearable and fully disposable insulin delivery device. EOFlow was at one point […]
