QT Vascular said today that it won an investigational device exemption from the FDA for a pivotal study of its Chocolate Touch drug-coated balloon. The device won the CE Mark for treating peripheral artery disease in September 2015 and in July it won approval for treating coronary artery disease. The Singapore-based company is slated to […]
FDA approves Bayer’s Kyleena IUD
Bayer (ETR:BAYN) said yesterday that it won FDA approval for its hormonal contraceptive device, Kyleena, to prevent pregnancy for up to 5 years. The German company said the long-acting reversible contraceptive (LARC) is due to hit the market next month. LARCs are an increasingly popular form of birth control, including intrauterine devices like Kyleena. Bayer’s […]
FDA approves 6-month endpoint in trial of Bard’s Lutonix 014 drug-coated balloon
C.R. Bard (NYSE:BCR) said yesterday that the FDA approved a supplemental investigational device exemption to change the main 6-month endpoint in the clinical trial of a new version of its Lutonix drug-coated balloon in treating below-the-knee peripheral arterial disease. Murray Hill, N.J.-based Bard in October 2014 won pre-market approval from the FDA for the Lutonix 035 DCB for PAD lesions above the […]
Medical society backs drug-eluting sinus implants
The American Rhinologic Society today endorsed the use of drug-eluting implants in sinus cavities for patients following surgery. A successful sinus surgery depends on proper healing and avoiding inflammation, the society said in a press release. Drug-eluting implants can reduce nasal polyps and inflammation, which can decrease a patient’s use of oral medication, according to […]
Microchip mimics human cells for drug trials
A physics professor from the University of Texas in Dallas reportedly created a microchip that mimics human cells to study the effects of cancer-fighting drugs. Jason Slinker, who started working on the chip in 2007 as a postdoctoral researcher, in 2010 began collaborating with David Boothman, an oncology professor at the University of Texas Southwestern […]
