AMF Medical announced today that it received FDA breakthrough device designation for its Sigi insulin management system. Ecublens, Switzerland-based AMF Medical’s Sigi (for diabetes mellitus treatment) can be programmed to deliver basal and bolus insulin at both set and variable rates. Get the full story at our sister site, Drug Delivery Business News.
Drug-Device Combinations
Medtronic plans to bring next-gen diabetes tech to FDA this fiscal year, no spinoff planned
Medtronic (NYSE:MDT) confirmed that it anticipates major regulatory steps for its next-generation insulin pump and sensor during this fiscal year. Medtronic’s fiscal years wrap up at the end of April. Speaking on the company’s second-quarter earnings call, Chair & CEO Geoff Martha said Medtronic expects its MiniMed 780G insulin pump system with the Guardian 4 […]
BioMarin wins FDA approval for injection to increase growth in children with dwarfism
BioMarin Pharmaceutical (NSDQ:BMRN) announced today that the FDA granted accelerated approval for its Voxzogo injection. San Rafael, California-based BioMarin’s Voxzogo (vosoritide) injection has an indication to increase linear growth in pediatric patients with achondroplasia (a form of dwarfism) five years of age and older with open epiphysis (growth plates). Continued approval may be contingent upon […]
ICU Medical’s Smiths Medical acquisition remains on track
ICU Medical (NASDAQ:ICUI) is a step closer to acquiring Smiths Medical after clearing a shareholders vote at Smiths’ British parent company, the Smiths Group. Almost all of the nearly 327 million Smiths Group shareholders voting on November 17 approved the $2.35 billion buy. Get the full story on our sister site Medical Tubing + Extrusion.
FDA gives Bexson pre-IND guidance for ketamine formulation delivered by wearable pump
Bexson Biomedical announced today that it received pre-investigational new drug guidance from the FDA for its ketamine compound therapy. Santa Barbara, California-based Bexson develops the patented BB106 formulation, a ketamine therapy delivered through a wearable, subcutaneous patch pump in development with Stevanato Group. Get the full story at our sister site, Drug Delivery Business News.
Diabeloop, Terumo partner to bring automated insulin delivery to Europe
Diabeloop announced that it entered into an agreement with Terumo with eyes on bringing automated insulin delivery solutions to Europe. Paris-based Diabeloop’s automated insulin delivery (AID) system automates and personalizes the treatment of insulin-dependent diabetes and contributes to reducing the mental burden associated with the metabolic disease. Get the full story at our sister site, Drug […]
How some diabetes tech companies are honoring National Diabetes Month
World Diabetes Day (Nov. 14) may have passed, but it remains National Diabetes Month through the end of November. A number of companies developing some of the most intriguing innovations in diabetes care have also stepped forward this month to organize awareness-raising efforts for the metabolic disease. Here are some steps a handful of diabetes technology developers […]
Stevanato Group expands corporate headquarters
Stevanato Group (NYSE:STVN) announced today that it expanded its corporate headquarters with a new facility in Italy. Based in Piombino Dese, Italy, Stevanato Group expects its 6,750-square-meter facility to support the optimization of its industrial footprint while advancing operations and growth within the company. Get the full story at our sister site, Drug Delivery Business News.
Cure Pharmaceutical wins patent approval for fast-dissolving drug delivery platform
Cure Pharmaceutical (OTC:CURR) announced today that it received confirmation of a patent for its Curefilm Blue platform.\ The U.S. Patent Office (USPTO) provided notification to Cure that U.S. Patent No. 11,179,331 (the ’331 patent) is set to issue on November 23, 2021. The ‘331 patent (“Oral Soluble Film Containing Sildenafil Citrate”) covers Curefilm blue. Get the […]
BD breaks ground on pre-filled syringe manufacturing plant in Spain
BD (NYSE:BDX) announced today that it broke ground on its $200 million pre-filled drug delivery device manufacturing plant in Spain. Franklin Lakes, New Jersey-based BD announced in May that it would build the $201.5 million (€165 million) high-tech manufacturing facility in Zaragoza, Spain, with expectations of creating up to 600 jobs at the facility by 2030. Get […]
7 diabetes treatment innovations to look out for on World Diabetes Day
World Diabetes Day — Nov. 14 — centers around raising awareness for those with diabetes. This year, that aim remains the same, and medical technology companies continue to look for ways to continue improving the management of the metabolic disease. Some of those treatments involve insulin, which was discovered as a treatment for diabetes in […]