Heart Test Laboratories MyoVista™ System Awarded European CE Mark for Heart Disease Screening
Heart Test Laboratories, Inc. today announced that the MyoVista™, its medical screening system which detects Myocardial abnormalities, has been awarded the CE Mark certification by TÜV SÜD. The CE mark (Conformité Européenne) is a mandatory European marking for certain product groups to indicate conformity with essential health and safety requirements.
“Being awarded the CE mark on our MyoVista™ system will give us a great boost into the European and Asian markets for heart disease screening,” said Heart Test Laboratories CEO, Drew Diaz. “The CE mark is also recognized globally as an indicator of high product quality control and manufacturing management.”
This milestone represents a significant step forward for broadening access to affordable heart disease screening," said Heart Test Lab’s CEO Drew Diaz. "We are hopeful that by making our state-of-the-art technologies more accessible abroad, we will play a role in reducing the global burden of heart disease."
In the broad scope of overseas competition, Mr. Diaz sees a direct link between the company’s ISO and CE marking certifications. "As we grow and develop internationally, we know that customers are looking for ISO certification to ensure that we have quality management systems in place to meet their expectations."