Edwards Lifesciences Corp. has been unstoppable so far this year, driven by the rapidly expanding adoption of transcatheter heart valve therapy. It beat expectations in its third-quarter earnings report, drawing praise and even higher expectations from Wall Street analysts. The Irvine, Calif.-based company recently received an expanded FDA indication for its Sapien 3 and Sapien 3 Ultra TAVR systems to treat surgical low-risk patients with severe aortic stenosis. (See BioWorld MedTech, Aug. 19, 2019.) Read More
CLEVELAND – Patents took center stage on the final morning of Cleveland Clinic's Medical Innovation Summit, with two experts shedding some light on the issues surrounding patentability – particularly in light of recent legal cases and a hearing before a subcommittee of the Senate Judiciary Committee. Read More
Dental devices would likely strike most observers as fairly simple items, but an FDA employee said on a recent webinar that these filings have a refuse-to-accept (RTA) rate in excess of 80%, suggesting sponsors have a lot of regulatory homework to do. The FDA finalized the RTA policy for 510(k) devices in September 2019, wrapping up a draft that originated in 2012, but which is on the second iteration. Read More
TORONTO – Winnipeg, Manitoba-based Medicure Inc. said results of a study released last week could nudge the door open wider in the U.S. for a device adapted from the military to normalize lung fluid content in patients suffering from heart failure. Read More
HONG KONG – South Korea's major pharmaceutical company GC Pharma Corp., based in Yong-in, Gyeonggi-do, and the Cambridge, Mass.-based U.S. biotech Vaxess Technologies Inc., have partnered to globally commercialize a flu vaccine patch based on Vaxess' Mimix Smart Release Patch technology. The patch is designed to deliver medicines and vaccines through silk microneedles that dissolve at a precise rate. Read More
