FDA Grants Breakthrough Device Status to SoniVie’s TIVUS System for PAH
The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough device to SoniVie’s Therapeutic Intra-Vascular Ultrasound (TIVUS) System for the treatment of people with pulmonary arterial hypertension (PAH). Similar to breakthrough therapy, the designation of breakthrough device is given to medical equipment…