EBR Systems, Inc. achieved ISO 13485 certification for its new Santa Clara manufacturing facility following assessment by the British Standards Institution.

EBR Systems, Inc. is driven to deliver superior treatment for millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective, and reliable therapies using wireless cardiac stimulation. The company’s initial product, the WiSE® CRT System, is a first-of-its-kind medical device developed to overcome the limitations of traditional Cardiac Resynchronization Therapy (CRT) in heart failure patients by eliminating the need for a lead to the heart’s left ventricle and the associated complications of that lead.