Boston Scientific wins CE Mark for Vercise brain stim device
September 17, 2014 by Brad Perriello
Boston Scientific said today that it won CE Mark approval to market its Vercise deep-brain stimulation device to treat essential tremor in the European Union.
Marlborough, Mass.-based Boston Scientific said the Vercise device features “neural targeting” designed to allow physicians to tailor therapy to individual patients and a rechargeable battery that lasts as long as 25 years. Read more
20 Years of Improving Women’s Health: 1994 – 2014
September 22, 2014 by MassDevice
As we celebrate the 20th anniversary of the FDA’s Office of Women’s Health, I would like to highlight some of the work we’ve done to help improve women’s health, both looking across FDA and within the office. Whether it is approving new treatments for chronic conditions like heart disease, conducting research or helping to protect pregnant women from foodborne illnesses, the work we do at FDA makes a difference throughout a woman’s life.
Consider our product approvals. In 1996, for example, our agency approved a product for use in Pap smears that revolutionized the detection of cervical cancer; ten years later we approved the first vaccine for the prevention of this cancer. We have also approved advances in breast imaging, including 3D breast tomosynthesis and automated screening ultrasound. Read more
Medtronic wins CE Mark for Tyrx cardiac device envelope
September 22, 2014 by Brad Perriello
Medtronic said it won CE Mark approval in the European Union for the Tyrx cardiac device envelope it acquired earlier this year and announced its immediate launch in countries that recognize the CE Mark.
The Tyrx envelope is an anti-bacterial mesh pouch used to cover implanted cardiac devices designed to reduce infections at the surgical site by releasing rifampin and minocycline before dissolving roughly 9 weeks after implantation of a pacemaker, ICD or CRT device. Read more
VertiFlex lands FDA panel date for Superion interspinous spacer
September 22, 2014 by Brad Perriello
VertiFlex Inc. won a date with an FDA advisory panel to review the data behind its Superion interspinous spacer ahead of its bid for pre-market approval from the watchdog agency.
VertiFlex is seeking the FDA’s permission to market the Superion in the U.S. under an indication for treating patients with lumbar spinal stenosis, according to a press release. Read more