Occlutech’s Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation
Occlutech, a privately-held company, announced today that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary Arterial Hypertension (PAH). PAH affects hundreds of thousands in the U.S. and globally and is resulting from changes in cells that causes damages […]
