FDAnews Device Daily Bulletin

FDA officials sounded a familiar drumbeat during a Tuesday meeting on ways to notify the agency about changes to PMA products, asking devicemakers to submit more complete information upfront to ensure their submissions can be processed quickly.

Two draft proposals intended to help European devicemakers and notified bodies prepare for the transition from three medical device directives (MDD) to two major regulations are beginning to circulate prior to the European Commission’s (EC) expected release of the draft regulations on Sept. 26, an expert says.

Roche Diagnostics announced it has received clearance from the FDA to market two automated tests for herpes simplex virus 1 and 2.

Mobile devices could assist individuals with autism spectrum disorder (ASD) find and retain paid work.

Mobile health devices that track vital signs are ready to take off, IMS Research predicts.

The ViSi Mobile System, a continuous vital signs monitoring device produced by Sotera Wireless, has received 510(k) clearance from the FDA.

Small is big for Murata: The Japanese electronics maker has developed the world's tiniest version of a component known as the capacitor.

A British woman paralyzed from the chest down by a horse riding accident has become the first person to take home a robotic exoskeleton that enables her to walk.