Fdanewsdevicedailybulletin

Jan. 30, 2012

Vol. 9 No. 20

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Guidance on Combination Knee Products Stresses Primary Endpoints

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. Read More

FDA Took Global View of GMPs, Tweaked Transparency in 2011

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. Read More

China Department of Health Issues Recall for Contact Lenses

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

St. Jude Medical CEO Says it Will Gain ICD Market Share in 2012

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. Read More

Parkinson’s Device Shows Promise in Trial

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. Read More

New Device Will Detect Infections, Cancer in Minutes

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

Medical Device Could Prevent Paralysis

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

Twin Cities Angels II Invests in Local Medical Device Firm

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

DHL Gains Healthcare Manufacturing License in Japan

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. Read More