Avita Medical (ASX:AVH) said today that the FDA approved a supplement to the company’s investigational device exemption for its ReCell autologous cell harvesting device. The approved treatment protocol for burn injuries has been simplified, according to the company, and the number of approved investigational sites has grown from eight to 15. Up until now, treatment using […]
Drug-Device Combinations
Eli Lilly’s Humalog Junior KwikPen diabetes drug-device combo launches in U.S.
Eli Lilly‘s (NYSE:LLY) Humalog Junior KwikPen insulin lispro injection is available in the U.S. by prescription for people with diabetes, the company said today. The drug-device combination product is designed as a pre-filled, disposable half-unit insulin pen. The Humalog Junior KwikPen won FDA approval in June this year and earlier last month, a European Medicines […]
First patient treated with CSA Medical’s AV spray catheter
CSA Medical said today that the first patient was treated using the company’s new rapid AV spray catheter for the management of persistent symptomatic esophageal cancer and associated dysplastic Barrett’s disease. The device uses a stainless steel catheter wall to cut the time needed to deliver liquid nitrogen spray to the treatment site by 50%, […]
Report: Mylan to pony up $20m to Massachusetts in EpiPen settlement
Mylan (NSDQ:MYL) is slated to pay $20.3 million to the Massachusetts Medicaid program to resolve claims that it underpaid the program by misclassifying its EpiPen device, according to attorney general Maura Healey. “Mylan knowingly misrepresented this drug to MassHealth in order to underpay on rebates and make a profit at the expense of our state,” Healey […]
Fifth patient treated in Flowonix, Cerebral Therapeutics epilepsy study
Flowonix Medical and Cerebral Therapeutics said today that the fifth patient was successfully treated in its Address trial, which features a micro-infusion device controlling drug delivery to a particular part of the brain in patients with medically refractory epilepsy. The study is the first of its kind, according to the companies. The Address trial is […]
DarioHealth launches smart diabetes tech in German market
DarioHealth (NSDQ:DRIO) said today that it launched its smart diabetes platform in Germany – the ninth country in which the Israel-based company’s technology is commercially available. DarioHealth’s platform includes a blood glucose monitoring system, which connects via a headphone jack to a mobile device. The system also includes a lancing device and test strips, together with […]
BioCorRx locks in Jan 2017 pre-IND FDA meeting for naltrexone implant
BioCorRx (OTC:BICX) said late last week it scheduled a pre-investigational new drug meeting with the FDA for its BICX102 naltrexone implant for next January as the company works on an IND application for the implant. The Anaheim, Calif.-based company said that its scheduled pre-IND meeting will not preclude it from submitting its IND application before that date. […]
Novo Nordisk wins FDA nod for fast-acting mealtime insulin
Novo Nordisk (NYSE:NVO) said today that the FDA approved its Fiasp insulin aspart injection. The fast-acting mealtime insulin is designed to improve glycemic control for adults with Type I and Type II diabetes. The injection can be taken at the start of a meal or within 20 minutes after starting a meal, Novo Nordisk reported. The […]
Why Bigfoot Biomedical’s CEO thinks the diabetes industry has a data problem
Bigfoot Biomedical‘s chief executive is excited about Abbott‘s (NYSE:ABT) latest regulatory win – and it’s not just because the two companies have an established partnership. Yesterday, the FDA approved Abbott’s FreeStyle Libre Flash continuous glucose monitoring system. It’s the first device of its kind, allowing patients to track their blood glucose levels without the use […]
Insulet “bets big” on Massachusetts with new manufacturing facility in Acton
Insulet (NSDQ:PODD) broke ground at its new manufacturing facility in Acton, Mass. yesterday, hosting a ceremony that featured the state’s governor, Charlie Baker, members of Baker’s administration and a young “Podder” named Lexi Bentinganan. Diagnosed at age 7 with Type I diabetes, Lexi has been using Insulet’s tubeless insulin delivery device, the Omnipod, since 2013. “It […]