FDAnews Device Daily Bulletin

The FDA is advising physicians and clinical trial sites that may be studying an experimental procedure for multiple sclerosis (MS) that they need to get investigational device exemption (IDE) approval to proceed.

A Form 483 to Midmark Corporation finds fault with corrective and preventive action (CAPA) procedures at its Versailles, Ohio, facility, as the plant did not analyze complaints for devices if they failed after the warranty period.

Devicemaker ArjoHuntleigh has issued a field safety notice for its Encore, Chorus and Sara Plus standing aids.

Florida State University announced today the availability of a new medical device that uses musical lullabies to help premature babies overcome one of their greatest growth hurdles.

All medical devices in Malaysia must be registered with the Medical Devices Authority (MDA) starting November this year, Health Minister Datuk Seri Liow Tiong Lai said.

A fecal incontinence test has won regulatory approval.

According to Millennium Research Group, the recent favorable physician reception to Biosense Webster’s new ThermoCool SmartTouch ablation catheter in Europe offers a number of useful lessons for product development, sales and marketing teams at cardiovascular device manufacturers.

Blood tests convey vital medical information, but the sight of a needle often causes anxiety and results take time.

ActiViews announced that China’s State Food and Drug Administration (SFDA) has granted clearance to market CT-Guide navigation for minimal invasive interventions.