FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization
SUNNYVALE, Calif.--(BUSINESS WIRE)--EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the WiSE CRT System for the treatment of heart failure. he FDA created this designation and its associated program in 2017 for certain devices providing more effective treatment of life-threatening or irreversibly debilitating disea