FDA Confirms CardiAMP HF II May Support Premarket Approval of CardiAMP Cell Therapy for Ischemic HFrEF
BioCardia, Inc. announced that the FDA confirmed its ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) for their CardiAMP Cell Therapy System targeting ischemic heart failure with reduced ejection fraction. The FDA highlights the potential for approval based on this pivotal trial amid recognition of the large patient popu…