MiniMed (Nasdaq: MMED) today reported Street-beating first-quarter revenue, upping its full-year sales guidance as it notched an early European regulatory win. The Northridge, California–based diabetes tech company, spun out of Medtronic earlier this year, announced a CE mark for its next-gen, app-controlled MiniMed Flex insulin pump — well ahead of the company’s calendar 2026 year-end target. […]
Regulatory/Compliance
GLP-1 therapies delivered by Stevanato Group pen injectors get green light in Europe
Stevanato Group announced today that liraglutide products incorporating its Alina pen injector received marketing authorization in Europe. Approved liraglutide-based combination products include Alina 30, developed for these therapies for diabetes, as well as Alina 50 for weight management applications. Both variants come as part of the company’s broader Alina variable-dose pen injector platform. The platform […]
MannKind closes $50M financing, wins FDA nod for Furoscix auto-injector
MannKind (Nasdaq:MNKD) announced today that it secured $50 million in a private placement and earned a new regulatory nod. In addition to the funding, the company — which also develops inhaled insulin technology — won FDA approval for the Furoscix ReadyFlow auto-injector. MannKind said it entered into a securities purchase agreement in connection with a […]
Baxter warns on intravascular administration sets
The FDA issued an early alert after Baxter (NYSE:BAX) recommended the removal of certain Duo-Vent intravascular administration sets. Baxter sent all affected customers a letter on June 30, telling them to immediately identify, quarantine and return affected lots. The communication affects lots DR26C27062, DR26D14031 and DR26E13055 of the Duo-Vent solution set and male luer lock adapter. Duo-Vent […]
Dexcom picks up Health Canada nod for G7 15 Day
Dexcom (Nasdaq:DXCM) announced today that Health Canada authorized its G7 15 Day continuous glucose monitor (CGM) system. Health Canada approval covers people 18 years and older living with diabetes. It brings the G7 15 Day, its longest-lasting wearable sensor, to Canada, with the system already possessing FDA clearance. G7 15 Day delivers several features of […]
Glucotrack expands IP to cover novel glucose monitor sensor architectures
Glucotrack (Nasdaq:GCTK) announced today that it secured new intellectual property allowance protecting its continuous blood glucose monitor (CBGM). The patent application, titled “Methods and Systems for Continuously Monitoring the Glucose Level of a Patient,” was allowed by the U.S. Patent and Trademark Office (USPTO), expanding the IP protecting the CBGM as Glucotrack looks to advance […]
FiberSense to bring new CGM to European market with CE mark
FiberSense announced today that it received CE mark approval for its continuous glucose monitoring (CGM) system. The FiberSense system is intended for the continuous monitoring of blood sugar levels and glucose trends in adults with diabetes. It uses advanced optical sensing technology to measure glucose concentrations in the tissue fluid beneath the skin (interstitial fluid). […]
FDA clears Dexcom Stelo over-the-counter CGM for children
Dexcom (Nadsaq:DXCM) has received FDA clearance for its Stelo over-the-counter (OTC) continuous glucose monitor (CGM) for children. The FDA said in a news release that it cleared Stelo for people two years of age and older who do not use insulin. It became the first OTC CGM system granted clearance in March 2024, initially getting […]
Tandem wins CE mark for automated insulin delivery in type 2 diabetes, pregnancy
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it received expanded CE mark for its automated insulin delivery (AID) systems. San Diego-based Tandem can now bring its Control-IQ-powered AID systems — the flagship t:slim X2 and miniature Mobi — to European adults with type 2 diabetes and those with type 1 diabetes during pregnancy. Approval in […]
CeQur announces extended wear time, added dosing for mealtime insulin patch pump
CeQur announced today that it picked up two recent FDA clearances for its Simplicity mealtime insulin patch pump system. The FDA cleared Simplicity for an extended wear time of up to seven days and gave the green light to a new 1-unit (1U) device. Additionally, Horw, Switzerland-based CeQur plans to share two clinical posters at […]
