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.
Despite falling short of its primary endpoint in a trial to examine its effects in cystic fibrosis patients with the R117H mutation, Vertex's Kalydeco has scored an FDA advisory committee recommendation for approval in that population. And the way some see it, that's a sign of much, much bigger approvals to come.
Reaction time can be a sign of brain injuries that are common on the battlefield such as concussion, dementia, post-traumatic stress and depression, says product developer AnthroTronix.
Johnson & Johnson's Janssen unit is recalling 13,500 bottles of its top-selling anticoagulant Xarelto because of microbial contamination.
FierceMedicalDevices caught up with Covidien Chief Medical Officer Dr. Michael Tarnoff at the annual AdvaMed conference in Chicago at the beginning of October. Tarnoff also performs minimally invasive and bariatric surgery part-time at Tufts Medical Center in Boston.
A panel of FDA advisers voted unanimously in favor of approving Novartis' new anti-inflammatory treatment, an expected positive outcome for the company as it races to be first in line among what promises to be a crowded field.
Sanofi's Pentacel, which protects children against 5 serious diseases, nabbed the No. 3 spot on the world's list of best-selling vaccines last year. Whether an investigational 6-in-1 combo from the French drugmaker and partner Merck can eventually match its success remains to be seen, but the pair is now one step closer to finding out.
The Office of Pharmaceutical Quality will finally open Jan. 1, and the FDA's Janet Woodcock will serve as its first acting director.
Dexcom won FDA approval for its next-generation mobile communications device for diabetes monitoring, chalking up another regulatory win and furthering the company's R&D push.
More than three dozen drugs and APIs that were originally banned by health regulators in Canada will be allowed into the country because they are medically necessary.