FDAnews Device Daily Bulletin

A plan to have CDRH’s Office of Device Evaluation (ODE) review 30-day notices of manufacturing changes, rather than the Office of Compliance, will first be piloted in the cardiovascular devices division.

The European Parliament and Council are wrapping up their review of a proposed regulation that would ban several types of mercury-containing medical devices because of their potential toxicities.

Some 40 patients with chronic venous leg ulcers will take part in a trial for the MIST Therapy system, which transmits ultrasonic energy to the base of wounds to stimulate tissue regeneration and remove dead tissue and bacteria.

Former ArthroCare senior executives John Raffle and David Applegate were arrested last week for alleged roles in a securities fraud scheme that cost shareholders more than $400 million.

The global medical-device market is a potential gold mine for plastics processors who understand complicated dynamics and are willing to work within the high barriers to entry.

GI Dynamics announced approval from the FDA to skip the pilot trial usually required for medical devices, allowing the company to move directly into a pivotal clinical trial of its lead product, a device for the treatment of obese patients who have uncontrolled Type 2 diabetes.

Tornier N.V. has agreed to buy OrthoHelix Surgical Designs for $135 million.

The FDA has issued two 510(k) clearances allowing Hollywog to market its WiTouch and WiTouch Pro wireless remote controlled devices for back pain.