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Endotronix Receives ISO 13485:2016 Certification
LISLE, Ill., April 24, 2019 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced that the company received ISO 13485:2016 certification from British Standards Institution (BSI) for its Quality Management System (QMS). Endotronix's adherence to internationally recognized standards for the medical device industry demonstrates their commitment to the highest level of product quality. They have developed a comprehensive heart failure solution, the Cordella™ Heart Failure System (Cordella System), which consists of a remote patient management platform and the implantable Cordella™ Pulmonary Artery Pressure Sensor (Cordella Sensor).
"We are focused on executing several key business, regulatory, and clinical milestones this year that ultimately drive the success of the company. The recent ISO certification ensures we are fully aligned with global regulatory requirements to provide a best-in-class product quality experience to our customers," commented Harry Rowland, CEO of Endotronix. "Similarly, we continue to make excellent progress with our comprehensive clinical program, which will show the real-world benefits of the Cordella System and create U.S. and E.U. market access for the Cordella Sensor."
The Cordella System is a comprehensive heart failure management solution that enables proactive management and early detection of worsening heart failure. The system can be seamlessly integrated with a next generation pulmonary artery (PA) pressure sensor, the Cordella Sensor, to streamline heart failure care management, reduce heart-failure-related hospitalizations, and support reimbursement for care delivery activities.
The Cordella System is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S. The Cordella Sensor is an investigational device and is not available for commercial use in any geography.
Endotronix, Inc., a medical technology company, delivers an integrated platform that provides comprehensive, reimbursable health management innovations for patients suffering from chronic heart failure. Their solution, the Cordella™ Heart Failure System, includes a cloud-based disease management data platform and at-home hemodynamic management with a breakthrough implantable wireless pulmonary artery pressure sensor for early detection of worsening heart failure. Learn more at http://www.endotronix.com.
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SOURCE Endotronix, Inc.