BG Medicine submits 510(k) to FDA for additional indication for BGM Galectin-3(R) test
BG Medicine reported that it has filed a 510(k) Premarket Notification with FDA for regulatory clearance of an additional indication for the BGM Galectin-3 Test. The BioImage Study enrolled men and women in the U.S. above the age of 55 and monitored them for major adverse cardiovascular events. March 31, 2015