Ypsomed plans to supply Bigfoot Biomedical with a modified version of its Orbit infusion set for the pivotal trial of Bigfoot’s automated insulin delivery system, the companies said today. Ypsomed’s Orbit infusion sets can be rotated 360°, giving users the freedom to move around, and are fitted using a heat-activated patch. The infusion sets are available with steel or […]
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FDA warns Magellan Diagnostics on lead tests
The FDA today warned Meridian Bioscience (NSDQ:VIVO) subsidiary Magellan Diagnostics based on the Class I recall of its lead poisoning tests, accusing the company of failing to protect patients after it learned of problems with the tests. The May recall, which was expanded in July, involves Magellan’s LeadCare, LeadCare II, Ultra and Plus products. The tests may underestimate blood lead levels […]
OptiScan CEO: Glucose monitor approval is biggest advancement for ICU care in 10 years
Just last week, OptiScan Biomedical announced that its OptiScanner 5000 glucose monitoring system won 510(k) clearance for use in surgical intensive care units. The regulatory win was supported by eight rigorous clinical trials, CEO Peter Rule told Drug Delivery Business News, and represents a victory for a technology that the company hopes to expand into a platform system. […]
Cerveau inks licensing deal with AbbVie for tau imaging agent
Cerveau Technologies has inked a deal to license and supply AbbVie (NYSE:ABBV) with its [F-18]MK-6240 investigational tau imaging agent, the company said today. After the FDA cleared the investigational new drug application for Cerveau’s imaging agent in June, the company said it planned to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans […]
United Therapeutics wins FDA nod for third-gen Tyvaso TD-300/A nebulizer
United Therapeutics (NSDQ:UTHR) said today that its third-generation inhalation device designed for use with its Tyvaso treprostinil inhalation solution won FDA approval. Tyvaso first won FDA approval in 2009 as a treatment for pulmonary arterial hypertension, the company said, with an ultrasonic nebulizer. United Therapeutics touted its drug-device combo as the most-prescribed inhalation therapy for PAD […]
FDA clears AstraZeneca’s once-weekly Type II diabetes drug-device combo
AstraZeneca (NYSE:AZN) said today that the FDA approved its once-weekly exenatide drug in a single-dose auto-injector for adults with Type II diabetes whose blood sugar is uncontrolled on one or more oral drugs. The company’s drug, Bydureon, is formulated with a continuous-release microsphere delivery system designed to provide consistent levels of exenatide, according to AstraZeneca, to […]
Lilly invests $72m in insulin manufacturing facility
Eli Lilly (NYSE:LLY) plans to invest $72 million in its Indianapolis-based insulin manufacturing facility, the company said today. The funds will be used to replace an existing insulin vial filling line, according to Lilly. The company said it plans to spend more money in the U.S., as long as the Trump administration moves forward with […]
Layoffs ahead for nearly 300 in Pennsylvania as J&J winds down Animas
Johnson & Johnson (NYSE:JNJ) plans to lay off nearly 300 workers in Pennsylvania as it winds down its Animas insulin pump business. The layoffs for 297 are slated for Animas operations in West Chester and Wayne, Pa., effective Dec. 15, according to a notice filed with the Commonwealth’s Dept. of Labor & Industry. J&J announced the […]
Surmodics goes head-to-head with Medtronic’s drug-coated balloon in pivotal trial
Surmodics (NSDQ:SRDX) announced today that the first patient was enrolled in a pivotal clinical trial evaluating its SurVeil drug-coated balloon. The 446-patient trial is designed to compare the company’s SurVeil device to Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon as a treatment for peripheral artery disease in the upper leg. “Based on the preclinical and early feasibility study […]
Medtech stories we missed this week: Oct. 20, 2017
From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD inks Chile distribution deal InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime […]