FDAnews Device Daily Bulletin
July 27, 2012 | Vol. 9 No. 147
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.
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.
Corindus Vascular Robotics has won clearance from the U.S. Food and Drug Administration for its robotic-assisted percutaneous coronary intervention system.
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.
A million-dollar grant is awarded to the University of Minnesota to expand one of its facilities.
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.
Those looking for medical device sales jobs may want to consider companies that develop and manufacture products to treat sleeping disorders.
Cardiovascular diagnostics developer BG Medicine has filed a 510(k) premarket notification with the FDA for regulatory clearance for the ARCHITECT Galectin-3 assay.
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