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BG Medicine, Inc.
BGMD today announced the filing of a 510(k) Premarket Notification with the U.S. Food and Drug Administration (FDA) for regulatory clearance for the ARCHITECT Galectin-3 assay, which is used with Abbott's fully automated ARCHITECT immunochemistry instrument platform.
The test measures a patient's blood level of galectin-3, a protein implicated in the progression of heart failure. Subject to FDA clearance, the new application would mark the first measurement of galectin-3 on an automated platform.
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