• Bio-Rad Laboratories (Hercules, California) reported that it has received FDA clearance for its BioPlex 2200 system, a new immunoassay platform that uses multiplexing technology to analyze for multiple disease states from single patient samples. It is the first clinical diagnostics platform to offer multiplexing technology on a fully automated, fully integrated random access platform, according to the company. Bio-Rad said the system would soon be available in the U.S.

• CoreValve SA (Paris) reported that it has received approval from the German government (Bezirksregierung Koln, state of Nordrhein-Westfalen, Cologne) to begin a clinical trial of its ReValving System to non-surgically replace diseased aortic heart valves in 10 patients who are contraindicated for open-heart surgery. Previously, CoreValve received local Institutional Review Board approval from The Heart Center (Seigburg, Germany), where the clinical trial will take place. The principal investigator will be Eberhard Grube, MD, chief of cardiology at The Heart Center and a consulting professor of medicine at Stanford University (Palo Alto, California), who will perform the ReValving procedure. The CoreValve procedure — with the CoreValve Percutaneous ReValving System — can be performed in a cardiac cath lab just like angioplasty and stenting, resulting in less trauma to the patient and cost savings to the healthcare system, the company said.

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