All Clarivate Analytics websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.
PERTH, Australia – Australia’s Parliament has passed the first tranche of medical device regulations reforms that follow a number of consultations over the last two years.
The U.S. FDA has granted breakthrough device designation to Mojo Vision Inc. for its first-of-a-kind true smart contact lens. The Mojo Lens, which features “invisible computing” and a built-in display, enables people to get timely information without having to look away from what they are doing or glance at a screen.
Device makers only can watch when cardiologists grapple with federal agency officials over device utilization. However, cardiologists are punching back hard against a rule used to judge whether a coronary artery stent is appropriately used, thus ensuring these devices won’t suffer a significant drop in utilization.
Transenterix Inc., of Research Triangle Park, N.C., said Tuesday that it has filed a 510(k) submission with the U.S. FDA for the Intelligent Surgical Unit (ISU), a machine vision system designed to work with its robotic Senhance surgical system. The new technology would equip users of the Senhance system with augmented intelligence to improve performance and surgical outcomes.
Abbott Park, Ill.-based Abbott Laboratories has gained the U.S. FDA’s nod for a clinical trial that will compare the effectiveness of Mitraclip to open-heart mitral valve surgical repair in people with primary mitral regurgitation (MR) who are eligible for open-heart surgery. The prospective, randomized REPAIR MR clinical trial is expected to enroll 500 patients at 60 sites in the U.S., Canada and Europe. The trial's design addresses the issue that, despite symptoms and increased mortality for individuals suffering from MR, patients often are undertreated by open-heart mitral valve surgery.
HONG KONG – Indian authorities have apparently given medical device manufacturers a one-year extension to register for market authorization that was originally to be done by the New Year.
The screening of at-risk patients for Barrett’s esophagus, a precursor to esophageal cancer, has long been a goal for health systems. Currently, most patients...
For biopharma, 2019 can be described as a terrific year – with a few asterisks. The financial markets were flourishing, with venture capital dollars, in...
Nurix Therapeutics Inc. landed its second big pharma collaboration in seven months when it signed with Sanofi SA to discover, develop and commercialize a pipeline...
The natural immune system has two lines of defense that complement each other. In response to an infection, a rapid but fairly unspecific and short-lived response...
BioWorld Premium
Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.
RSS
