Boston Scientific Corp., of Marlborough, Mass., has won the U.S. FDA’s nod for the Exalt Model D single-use duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. It is the first single-use duodenoscope on the market and earlier secured breakthrough device designation. “Unlike duodenoscopes that are used on multiple patients, a fully disposable duodenoscope doesn’t need to be reprocessed, eliminating the risk of potential infection due to ineffective reprocessing,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
The Watchman left atrial appendage device, distributed by Marlborough, Mass.-based Boston Scientific Corp., holds a unique place in the annals of med tech regulation, but 50-month data from two registries show a lower rate of hemorrhagic stroke than previously reported for the device.
SAN JOSE, Costa Rica – 3D printing has emerged as a source of tangible solutions to multiple challenges facing the medical technology industry, and some of the largest companies in the space are already looking at and using this rapidly evolving technology. Med-tech manufacturer Boston Scientific Corp., for instance, is using 3D printing across multiple plants around the world, including its two manufacturing facilities in Costa Rica.
A relief rebound drove Boston Scientific Corp. up 6% on positive third-quarter earnings news. But that wasn't enough to recover all the ground that shares (NYSE:BSX) of the Marlborough, Mass.-based medical device giant lost last month on the disappointing next-generation transcatheter aortic valve replacement (TAVR) study results presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference held last month in San Francisco.
SAN FRANCISCO – As the transcatheter aortic valve replacement (TAVR) field matures, it is becoming increasingly difficult to develop a new implant that can distinguish itself vs. competitors. The incremental benefits are narrowing rapidly, making it tough to distinguish new iterations from one another using standard, randomized trials.
BOSTON – What are companies doing to be successful in the current environment of med-tech M&A valuation? That question was posed to panelists from three top device makers during the Medtech Conference Tuesday morning. Specifically, the panel, which featured representatives from New Brunswick, N.J.-based Johnson & Johnson, Medtronic plc and Boston Scientific Corp., looked at overall valuations across the sector, as well as what it takes to produce a successful M&A strategy.
