We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
French medical devicemaker Carmat hopes to wrap up clinical studies of its artificial heart in Europe in time for a 2015 launch date — with eyes on U.S. market entry sometime thereafter. Read More
ITGI Medical and Vascular Solutions plan to begin enrolling patients in a humanitarian device exemption trial of ITGI’s Aneugraft Dx coronary stent during the first quarter of next year. Read More
Australia’s medtech field is growing rapidly, grossing roughly US $93 billion in 2012 and claiming a total of 41,292 devices on the Australian Register of Therapeutic Goods, a new industry report shows. Read More
Medical devicemakers should be aware that they have become “lower-hanging fruit” for FDA enforcement of off-label promotion rules, and so have online product communications, two experts say. Read More
A federal court in California has ruled that using conventional diagnostic techniques in concert with a natural phenomenon does not add enough to make the end product patent-eligible. Read More
Seattle-based Atossa Genetics has initiated a Class I recall of all lots of its Mammary Aspiration Specimen Cytology Test (MASCT) and the accompanying patient sample kit, along with the ForeCYTE Breast Health Test Kit, manufactured between Jan. 9 and Sept. 13, 2013. Read More
A group of patient advocacy organizations is urging Congress to pull back on proposed cuts in Medicare coverage for medical imaging, saying further reductions will seriously impede access to life-saving screening and radiation therapy services. Read More
Solta Medical, a California-based maker of devices to remove fat and improve skin, is considering hanging out a for sale sign after four consecutive quarters of lower-than-expected sales of its Liposonix and Fraxel brands and increased market competition Read More
California start-up Scanadu expects to begin clinical trials of its Scanadu Scout medical tricorder in early 2014, after securing $10.5 million in Series A financing from Relay Ventures, VegasTechFund and Ame Cloud Ventures. Read More
Smith & Nephew announced the U.S. launch of its Healicoil Regenesorb suture anchor at the Arthroscopy Association of North America Fall Course in Las Vegas. Read More