The FDA today released a medical device safety communication warning of air-in-line and air embolism risks, as well as the risks of false alarms for such events, with infusion pumps, fluid warmers and rapid infusers. The FDA reinforced the dangers of air-in-line issues, which can lead to potentially life-threatening air embolisms, but also warned of […]
FDA rejects Sunovion’s NDA for Parkinson’s disease-treating apomorphine sublingual film
Sunovion Pharmaceuticals said yesterday that the FDA rejected its New Drug Application for its apomorphine sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease. The Marlborough, Mass.-based company’s product is a fast-acting therapy based on a novel formulation of an FDA-approved drug, apomorphine. Sunovion is assessing its apomorphine sublingual film as a therapy […]
Surmodics posts Street-beating FY2019 Q1 earnings
Surmodics (NSDQ:SRDX) today posted fiscal year 2019 first quarter earnings that beat expectations on Wall Street. The Eden Prairie, Minn.-based company posted profits of $1.3 million, or 9¢ per share, on sales of approximately $22.2 million for the three months ended December 31, seeing a swing from the red on the bottom line while sales grew […]
Report: Medtronic, Boston Scientific stand by paclitaxel-eluting devices despite JAHA study
Major medtech players Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) continue to support the use of their paclitaxel-eluting devices in the legs after a study released last month indicated a link between the devices and an increased mortality rate, according to a Star Tribune report. In the meta-analysis, researchers led by Dr. Konstantinos Katsanos analyzed data from 28 […]
Ablative Solutions closes $77m Series D
Ablative Solutions said today that it closed a $77 million Series D funding round slated to help support its technology platform intended to treat hypertension. The round was led by newly invested Gilde Healthcare and co-led by existing investor BioStar Ventures and an undisclosed new strategic corporate investor, the Kalamazoo, Mich.-based company said. Existing investors […]
Dexcom prices $750m debt offering
Dexcom (NSDQ:DXCM) today priced its $750 million offering of convertible senior notes due 2023 which is slated to be offered to qualified institutional buyers. The San Diego, Calif.-based company said that it will also offer a 13-day option to buy up to an additional $100 million aggregate principal amount of notes to purchasers in the offering. […]
Propeller Health touts link between air pollution, rescue inhaler use in nationwide asthma study
Propeller Health today touted results from a nationwide study that indicated a direct association between daily air pollution and rescue inhaler use. Results from the study, which spanned five years and involved more than 2,800 individuals with asthma, were published in the Proceedings of the National Academy of Sciences, the Madison, Wisc.-based company said. Researchers in […]
Medtronic inks deal to acquire nutrition tech group Nutrino Health
Medtronic (NYSE:MDT) said today that it inked a deal to acquire nutrition tech company Nutrino Health for an undisclosed amount, with plans on integrating it into the company’s diabetes division. Nutrino Health provides nutrition-related data services, analytics and technologies, Fridley, Minn.-based Medtronic said. The company added that it plans to integrate Nutrino’s food analysis infrastructure, nutrition […]
Tandem Diabetes Q3 sales top The Street
Tandem Diabetes Care (NSDQ:TNDM) today posted third quarter earnings and lifted its sales guidance for the year, beating Wall Street expectations for the quarter in sales but falling behind on losses per share. The San Diego-based company posted losses of $34.2 million, or 62¢ per share, on sales of $46.3 million for the three months ended […]
Insulet Q3 beats The Street
Insulet (NSDQ:PODD) today posted third quarter earnings that beat expectations on Wall Street and lifted its guidance for the remaining year. The Billerica, Mass.-based company posted profits of $1.7 million, or 3¢ per share, on sales of $151.1 million for the three months ended September 30, seeing a 174.5% swing into the black while sales grew 24.1% […]
