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BG Medicine
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CE Mark to Bg Medicine Automated Galectin-3 Blood Test Is Granted by EU
Jan 5, 2013BG Medicine has obtained CE mark certification for its automated Galectin-3 blood test, designed for the management of chronic heart failure. The test will be made available through bioMerieux's VIDAS immunoassay, which consists of about ...
Tags: EU, CE Mark, BG Medicine, Medicine
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Galectin-3 Testing Services of BG Medicine are distributed by Atherotech
Dec 19, 2012Atherotech Diagnostics Lab, a CLIA-certified clinical reference laboratory, has entered into an agreement to offer BG Medicine's galectin-3 testing services to laboratory customers and physicians. To offer the services, Atherotech is ...
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BG Medicine's CardioSCORE Test Has Received CE Mark
Dec 18, 2012BG Medicine's CardioSCORE test has received CE Mark, which enables the commercial sale of it in the EU and other countries that recognize the CE Mark. The CardioSCORE test is a patented diagnostic blood test designed to improve risk ...
Tags: BG Medicine, Cardioscore Test, blood test, Medicine
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BG Medicine Has Obtained Ce Mark Approval for Its Diagnostic Blood Assay, CardioSCORE
Dec 14, 2012BG Medicine has obtained CE mark approval for its diagnostic blood assay, CardioSCORE, designed for identifying individuals who are at high risk for near-term major cardiovascular events including heart attack and stroke. The multivariate ...
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BG Medicine Has Registered a 510(K) Premarket Notification with The US FDA
Dec 7, 2012BG Medicine has registered a 510(k) premarket notification with the US Food and Drug Administration (FDA) for approval of its Architect Galectin-3 assay. The Architect Galectin-3 assay, which is designed for use with Abbott's automated ...
Tags: BG Medicine, premarket notification, FDA, Architect Galectin-3 assay
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BG Medicine Has Filed 510(K) Premarket Notification
Dec 5, 2012BG Medicine has filed 510(k) premarket notification for regulatory clearance of an expanded indication for its BGM Galectin-3 test with the FDA. The blood test is at present indicated for use in patients with chronic heart failure who are ...
Tags: BG Medicine, blood test, heart failure
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BG Medicine Filed a 510(K) Premarket Notification for ARCHITECT Galectin-3 Assay
Dec 5, 2012Cardiovascular diagnostics developer BG Medicine has filed a 510(k) Premarket Notification with the US Food and Drug Administration (FDA) for regulatory clearance for the ARCHITECT Galectin-3 assay. Used with Abbott's fully automated ...
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BG Medicine Has Announced The Availability of Galectin-3 Testing Services
Dec 5, 2012BG Medicine has announced the availability of galectin-3 testing services through Atherotech Diagnostics Lab. Atherotech leverages BGM Galectin-3 test to offer galectin-3 testing. The BGM Galectin-3 test was cleared as an aid in ...
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