WASHINGTON – The 2019 annual forum hosted by the Medical Device Innovation Consortium (MDIC) takes place as the National Evaluation System for health Technology (NEST) approaches full operability. Acquiring the data needed to employ NEST as a source of real-world evidence (RWE) is still an issue. Harlan Krumholz, a cardiologist and health care researcher at Yale University and Yale-New Haven Hospital, said that disruption of the business models of the "data oligopolies" is critical for use of RWE for devices in both the pre- and postmarket settings. Read More
BEIJING – The ongoing trade war between the U.S. and China has helped put the biotechnology field on the U.S. foreign investment restriction list, causing a chilling effect on the market. With the amount of Chinese money entering the U.S. biotech sector dropping sharply, many believe it is the U.S. that is taking the hit. Read More
Abbott Laboratories has kicked off a pivotal study to evaluate its catheter-based Triclip transcatheter tricuspid valve repair system in patients with severe tricuspid regurgitation (TR). The first enrollments in the U.S. FDA-approved Triluminate study were performed at Abbott Northwestern Hospital in Minneapolis by a cardiac team led by Paul Sorajja, director of the Center for Valve and Structural Heart Disease at the Minneapolis Heart Institute and co-primary investigator for the trial. Read More
