FDAnews Device Daily Bulletin

Primary endpoints for Phase III clinical trials of combination products used to repair knee cartilage should be either improvement in physical function or reduction of pain, according to an FDA final guidance.

As promised, the FDA last year moved to tighten up loose links in the global device supply chain while addressing criticism that agency decisionmaking is too often opaque.

The Chinese Department of Health has issued a voluntary recall for Biomet Microfixation’s Sternalock Blu Implant Tray.

Despite its troubles related to the Riata and the Riata ST lead recalls, St. Jude Medical CEO Daniel Starks told analysts the company will gain a 1 percentage point market share in the global cardiac rhythm market in 2012.

What could be one of the most significant advances in the treatment of Parkinson’s disease in the last 50 years has been under testing at 15 medical centers around the country.

Toronto’s medical community is buzzing about an invention that could change the way health professionals screen for infectious disease and cancer.

A medical device invented more than 40 years ago could prevent paralysis, however many hospitals have stopped using it.

InterValve said it received an undisclosed investment from local group Twin Cities Angels II.

DHL Supply Chain has developed a new temperature controlled area dedicated to medical device manufacturers within its Tokyo Logistics Centre, and received a medical device manufacturing license from the Tokyo Metropolitan Government for the center in Yashio, Shinagawa.