Beta Bionics announced that it successfully closed a Series D funding round, securing $100 million in new equity capital. Concord, Massachusetts-based Beta Bionics develops its flagship iLet bionic pancreas. The autonomous insulin delivery system streamlines diabetes management and reduces the burden on patients and physicians. iLet received FDA clearance in May. While Beta Bionics did […]
Emergent BioSolutions launches over-the-counter Narcan nasal spray
Emergent BioSolutions (NSYE:EBS) announced today that it plans to put its over-the-counter Narcan nasal spray on U.S. shelves next month. FDA approved the over-the-counter Narcan spray in May. Approval enabled direct-to-consumer sales in places like drug stores, convenience stores and more. The FDA nod came about six weeks after an agency committee voted unanimously in favor […]
Implantable CGM maker Glucotrack names new VP of marketing
Glucotrack (Nasdaq:GCTK) announced that it appointed Drinda Benjamin as its new vice president of marketing. Rutherford, New Jersey-based Glucotrack develops an implantable continuous glucose monitor (CGM). It designed its CGM for patients with type 1 and type 2 insulin-dependent diabetes. A recent feasibility study demonstrated reliable glucose measurements for two years post-implant for the device. […]
FDA clears new infusion pump and software from ICU Medical
ICU Medical (Nasdaq:ICUI) announced today that the FDA granted 510(k) clearance to its Plum Duo infusion pump with LifeShield infusion safety software. The San Clemente, California-based company plans to make the pump and software available to U.S. customers in early 2024. Plum Duo, the latest addition to the ICU Medical infusion device portfolio, builds on […]
Dexcom appoints a new board director
Dexcom (Nasdaq:DXCM) announced today that it appointed Rimma Driscoll to its board of directors. The San Diego-based continuous glucose monitor (CGM) maker made Driscoll’s appointment effective on Aug. 24. She currently serves as EVP and head of global strategy, commercial and business development and global biodevices for Zoetis. At Zoetis, a leading animal health company […]
Insulet fully launches Omnipod 5 in Germany, expects full European availability by end of 2024
Insulet (Nasdaq:PODD) announced today that it commercially launched its Omnipod 5 automated insulin delivery system in Germany. Acton, Massachusetts-based Insulet released the device for individuals aged two years and older with type 1 diabetes. Germany marks the third market for the latest-generation patch pump. The company launched Omnipod 5 in the U.S. in August 2022, […]
Vaxxas wins $3.7M award to support needle-free typhoid vaccine tech
Vaxxas announced that it received a $3.67 million award to conduct studies of a typhoid vaccine delivered by its needle-free device. The company develops a vaccine patch based on its proprietary HD-MAP delivery technology. Vaxxas designed its HD-MAP technology to use an ultra-high-density array of micro projections, invisible to the human eye. Applied to the […]
2-year data backs DarioHealth digital diabetes platform
DarioHealth (Nasdaq:DRIO) today announced new research demonstrating sustainably improved outcomes with its digital diabetes platform. New York-based DarioHealth designed its digital health solutions to combine a clinically intelligent platform with consumer insights. It helps to drive sustainable behavior change to improve the management of chronic conditions, including diabetes. The research, presented at the ADCES23 Annual […]
Welldoc gets FDA nod for CGM-guided insulin bolus dosing software
Welldoc announced today that it won the 11th FDA 510(k) clearance for its BlueStar digital diabetes management platform. The clearance comes just a week after BlueStar received its 10th FDA clearance for using connected insulin dosing data in personalized bolus insulin dosing recommendations. Welldoc’s newest clearance enables BlueStar to provide bolus insulin dose recommendations based […]
Medtronic pleased with Diabetes progress as new CGM’s FDA review ‘is progressing’
After ending fiscal 2023 on a high, the Diabetes unit at Medtronic (NYSE:MDT) continues to roll on into the company’s new fiscal year. To finish fiscal 2023 (in April), Medtronic received FDA approval for its next-generation MiniMed 780G automated insulin delivery system. Shortly after, the company fully resolved a warning letter issue with the FDA. […]