The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Aria CV Pulmonary Hypertension System (Aria CV PH System).
The Breakthrough Devices Program (BDP) is intended to expedite the FDA review and approval of designated devices that may provide more effective treatment of life-threatening or irreversibly debilitating diseases. BDP is intended to help patients gain faster access by expediting designated device development, assessment, and review, while preserving the statutory standards for premarket approval, consistent with the FDA’s mission to protect and promote public health.
You can read the full article here: Aria CV Receives FDA Breakthrough Designation for Device to Treat Pulmonary Arterial Hypertension