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July 27, 2012

Vol. 9 No. 147

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St. Jude CEO Predicts Recovery Ahead Despite Slow Second Quarter Revenues

The sluggish cardiac rhythm management (CRM) sector should hit bottom by early 2013 and then begin a slow comeback, St. Jude Medical CEO Dan Starks said in a July 18 conference call to discuss the company’s second quarter 2012 earnings. Read More

Medtronic Unit Gets Form 483 for Process Control Issues

Medtronic Spine received a Form 483 for various process control deviations at the conclusion of a Nov. 28, 2011 – Dec. 5, 2011, inspection at its Sunnyvale, Calif., plant. Read More

Corindus Gets FDA OK for Robotics System

Corindus Vascular Robotics has won clearance from the U.S. Food and Drug Administration for its robotic-assisted percutaneous coronary intervention system. Read More

Covidien Fiscal 3Q Profit Falls 15 Percent

Covidien’s fiscal third-quarter earnings fell 15 percent, as some expenses jumped and foreign exchange rates dampened revenue growth for the Irish drug- and devicemaker. Read More

University Medical Devices Center gets $1M grant

A million-dollar grant is awarded to the University of Minnesota to expand one of its facilities. Read More

FDA, Guided Therapeutics Unveil Plan for Rejected LuViva Cervical Scanner PMA

Guided Therapeutics made new progress on its once-rejected pre-market approval bid for the LuViva advanced cervical cancer scanning system, which the FDA knocked with a “not approvable” letter in January. Read More

Sleep Apnea Medical Device Sales Market Expected to Grow Through 2017

Those looking for medical device sales jobs may want to consider companies that develop and manufacture products to treat sleeping disorders. Read More

BG Medicine Seeks FDA Clearance for ARCHITECT Galectin-3 Assay

Cardiovascular diagnostics developer BG Medicine has filed a 510(k) premarket notification with the FDA for regulatory clearance for the ARCHITECT Galectin-3 assay. Read More