Boston Scientific expects an FDA approval of its controversial stroke-fighting device Watchman during the first half of next year coming off its third positive FDA panel, despite a checkered regulatory past that includes a 2010 rejection due to safety concerns.
Boston Scientific won CE-mark approval for a new suite of MRI-friendly pacemaker products, boosting its product offerings and furthering its plan of revitalizing sales for its sluggish cardiac unit.
Boston Scientific won a positive recommendation from an FDA panel for its stroke-fighting Watchman device, even as panel members expressed doubt that the product would work well in patients who are eligible for traditional drug therapy.
The long slog toward approval for Boston Scientific's Watchman implant continues today when it goes before a FDA advisory panel for a third time.
Boston Scientific owes $309 million in royalties and other expenses to Mirowski Family Ventures, associated with the deceased Dr. Michel Mirowski, principal inventor of the the pacemaker, said a jury in Maryland's Montgomery County Circuit Court yesterday.
Boston Scientific was dealt a crushing blow in its vaginal mesh saga, as a Texas state jury ordered the devicemaker to pay $73 million to a woman who claimed chronic pain and injury from the company's vaginal mesh implant.
Boston Scientific is facing a stinging setback in the highly competitive neuromodulation field as the company's vagus nerve stimulation (VNS) device failed to improve cardiac function in a recent mid-stage clinical trial.
Boston Scientific faces more than 23,000 lawsuits over its Pinnacle transvaginal mesh device. Last week it failed to remove four cases from a consolidated multidistrict litigation suit in the U.S. District Court for Western Virginia.
Jazz Pharmaceuticals and Boston Scientific have begun using Box as their main platform for managing and collaborating on content.
Boston Scientific has just announced plans to launch new fractional flow reserve and atherectomy guidewires in 2015 in collaboration with Japanese medical component specialist Asahi Intecc.