BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure
On February 03, 2022, The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP® Cell Therapy System for the treatment of heart failure, according to BioCardia®, Inc., a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. It was thought to be the first cardiac cell therapy to be designated as a Breakthrough Device by the FDA.
Carl Pepine, MD, MACC, Professor in the Division of Cardiovascular Medicine at the University of Florida said, “It is exciting for ...
