BG Medicine, Inc. announced that it has submitted to the FDA a notice of withdrawal of its 510(k) premarket notification filing with the US Food and Drug Administration that was submitted in order to obtain regulatory clearance to market its BGM Galectin-3® Test for a potential new indication for use as an aid in the assessment of the near-term risk of fatal cardiovascular events in older adults who have no prior history of cardiovascular disease, cerebrovascular disease or vascular disease. As previously disclosed, on March 31, 2015, BG Medicine filed for 510(k) premarket notification with the FDA in order to obtain regulatory clearance for this new indication for the manual micro-titer formatted (manual version) BGM Galectin-3 Test. In August 2015, it has received a request for additional information from the FDA, including information regarding the intended use of its test for this new indication, its clinical validation study and additional statistical analyses.

It submitted its response to the FDA in November 2015. On December 17, 2015, it conducted a follow up discussion with the FDA regarding its November 2015 response.