Valeritas (NSDQ:VLRX) said today that it launched its V-Go wearable insulin delivery device in Australia. The company inked an exclusive distribution agreement in Australia with AMSL Diabetes earlier this year. According to the terms of the deal, Valeritas will be responsible for product development, regulatory approval, quality management and manufacturing. AMSL Diabetes will take over the […]
Dexcom acquires diabetes management tech with TypeZero purchase
Dexcom (NSDQ:DXCM) said this week that it acquired TypeZero Technologies and its personalized diabetes management solutions. The financial details of the transaction were not disclosed. Dexcom plans to support the first commercial launch of an automated insulin delivery system using TypeZero’s inControl algorithm next year. In March, Dexcom’s latest continuous glucose monitor became the first CGM to […]
Urotronic raises $20m for drug-coated balloon catheter
Urotronic has raised $20 million in an equity offering involving 7 investors, according to a document filed with the SEC this week. The Minnesota-based company is developing a drug-coated balloon catheter designed to treat urethral strictures in men. Urotronic’s latest fundraising efforts come on the heels of a $6 million offering that closed in July. Earlier this year, […]
FDA extends expiration date for swath of Mylan’s Epipens amid shortage
In an attempt to mitigate an ongoing shortage of Epipen auto-injectors, the FDA today extended the expiration date of specific lots of 0.3-mg devices by four months. The move to extend the expiration dates beyond the approved 20-month shelf-life is based on stability data provided by Mylan (NSDQ:MYL) to the FDA, the U.S. regulatory agency reported. “Many […]
Ichor touts use of electroporation drug-delivery system in cervical cancer trial
Ichor Medical Systems said today that its TriGrid electroporation drug-delivery system was tapped for a Phase Ib/II clinical trial to administer an investigational therapeutic HPV DNA vaccine, GX-188E, developed by Genexine Inc. The trial is designed to test the efficacy of a DNA vaccine combined with an anti-PD-1 therapy in patients with HPV-induced advanced non-resectable […]
Xeris Pharmaceuticals kicks off dual-hormone artificial pancreas trial
Xeris Pharmaceuticals (NSDQ:XERS) said last week that it launched a Phase I trial of its ready-to-use liquid glucagon in a closed-loop, dual-hormone artificial pancreas system. Automated insulin delivery systems represent the latest advancement in diabetes management. But these technologies fall short of performing the tasks of a human pancreas – they deliver insulin, but they […]
Tandem launches insulin pump with predictive low glucose suspend feature in US
Tandem Diabetes Care (NSDQ:TNDM) last week launched its t:slim X2 insulin pump with Basal-IQ technology in the U.S. The company’s latest pump includes a predictive low glucose suspend feature designed to reduce the frequency and duration of hypoglycemia. Using the Basal-IQ algorithm, the system predicts where a user’s blood sugar levels are heading up to 30 […]
Voluntis launches upgraded digital insulin dosing therapeutic
Voluntis this week launched an upgraded version of Insulia, its digital therapeutic designed to give automated basal insulin dose recommendations and coaching messages for people with Type 2 diabetes. The company touted that its upgraded version of Insulia improves user experience and offers Spanish programming. “Over the past year, we’ve worked closely with the medical community […]
FDA approves first generic Epipen
The FDA this week approved the first generic version of Mylan‘s (NSDQ:MYL) Epipen emergency allergy auto-injector. Teva Pharmaceuticals (NYSE:TEVA), which won the historic approval, plans to market the generic epinephrine auto-injector in 0.3mg and 0.15mg doses. There are other epinephrine auto-injectors on the market in the U.S., but Teva’s is the first that’s approved to directly […]
Lessons learned: How Jeff Karp stays at the forefront of innovation
Serial entrepreneur Jeff Karp has a philosophy for his laboratory: find important problems and get solutions to people quickly. To learn about the exciting technologies emerging from Karp’s lab, join us at DeviceTalks Boston on Oct. 8-10. After Jeff finished his PhD in chemical and biomedical engineering at the University of Toronto, he knew he wanted […]
