Access Vascular said today that its HydroPICC catheter has won 510(k) clearance from the FDA. The peripherally-inserted central catheter is designed with Access Vascular’s proprietary bulk-hydrophilic material, which the company touted as “the ideal material for long-term implantable vascular access devices.” “The FDA clearance of the HydroPICC catheter is an important milestone for Access Vascular […]
Anika posts mixed Q4, FY17 results
Shares in Anika Therapeutics (NSDQ:ANIK) rose today after the company topped earnings expectations on Wall Street with its fourth quarter and full-year financial results, but missed sales estimates. The Bedford, Mass.-based company posted profits of $8.1 million, or 55¢ per share, on sales of $29.3 million for the 3 months ended Dec. 31, for bottom-line loss of […]
Insulet beats the Street with Q4, FY17 sales
Insulet (NSDQ:PODD) reported yesterday that the insulin delivery device-maker topped sales expectations on Wall Street for its fourth quarter and full-year financial results, but missed earnings estimates. The Billerica, Mass.-based company reeled in losses, posting -$6.9 million on sales of $130.5 million for the 3 months ended Dec. 31, for sales growth of 26% compared with […]
Novocure misses Q4 EPS by a penny, tops sales estimates
Shares in Novocure (NSDQ:NVCR) rose slightly today in premarket activity after the medical device maker met sales expectations, but missed earnings estimates on Wall Street with its fourth quarter and full-year financial results. The St. Helier, N.J.-based company reeled in losses this quarter, posting -$10.9 million on sales of $53.7 million for the 3 months ended Dec. […]
Express Scripts to include Novo Nordisk’s once-weekly diabetes drug on 2018 formulary
Express Scripts, one of the nation’s largest pharmacy benefit managers, reportedly plans to include Novo Nordisk‘s (NYSE:NVO) once-weekly Type II diabetes, Ozempic, on its 2018 formulary. The move puts Ozempic directly in competition with Eli Lilly‘s (NYSE:LLY) once-weekly Trulicity drug. Both products will also go up against AstraZeneca‘s (NYSE:AZN) once-weekly Bydureon medication. Get the full story at our […]
Pieris Pharmaceuticals closes $51m public offering
Pieris Pharmaceuticals (NSDQ:PIRS) has closed an underwritten public offering of 6,325,000 shares of its common stock. The Boston, Mass.-based company said it reeled in $50.6 million from the offering, which it plans to use to fund the pre-clinical and clinical development of its pipeline. Get the full story at our sister site, Drug Delivery Business News.
Medtronic expands insulin pump portfolio with MiniMed Mio infusion set
Medtronic (NYSE:MDT) has launched its MiniMed Mio Advance infusion sets, which are designed for people managing their diabetes with insulin pump therapy. The medtech titan touted its product, which was developed by ConvaTec, as boasting a user-friendly design that allows patients to access hard-to-reach sites, like the lower back. The infusion system has no visible needle […]
Tandem Diabetes bids for Health Canada nod
Tandem Diabetes Care (NSDQ:TNDM) has submitted a medical device license application to Health Canada in the hopes of launching its t:slim X2 insulin pump in Canada in the second half of this year. The San Diego, Calif.-based company expects that its device will be able to display both English and French and will include a 24-hour […]
Senseonics’ implantable glucose monitor succeeds in 90-day trial
A 90-day trial involving patients with Type I and Type II diabetes showed that Senseonics‘ (NYSE:SENS) implantable continuous glucose monitor was safe and accurate compared to reference glucose values, according to a study published in Diabetes Technology & Therapeutics. The single-arm study enrolled 90 participants and implanted them with Senseonics’ Eversense device, which sends glucose data every […]
Pacira shares fall after FDA committee rejects expanded use for Exparel pain drug
Shares in Pacira Pharmaceuticals (NSDQ:PCRX) fell nearly -16% today after a panel of experts convened by the FDA voted against an expanded use for Pacira’s injectable pain drug. The pharmaceutical company previously submitted an application seeking to use the local anesthetic as a regional pain-killer. Get the full story at our sister site, Drug Delivery Business News.
FDA issues warning for Roche’s Accu-Chek diabetes management app
The FDA today issued a Class 2 device recall for Roche‘s (OTC:RHHBY) Accu-Chek connected diabetes management app. The company first notified the regulatory agency of the software bug in June last year. Roche reported that certain iOS and Andriod versions of the app had a program error in the Bolus Advisor feature – a calculator that helps the […]