Neovasc Inc . (“Neovasc” or the “Company”) ( Nasdaq , TSX : NVCN) announced today that it has received a “not-approvable” letter from U.S. Food & Drug Administration (FDA) regarding its PMA submission for the Neovasc Reducer™ (Reducer). Fred Colen, Neovasc CEO, said, “While we are disappointed in FDA’s decision, the letter was not unexpected, given the outcome of the Panel meeting.” He continued, “Milli
January 15, 2021
· 2 min read