HeartSciences has announced the launch of its MyoVista high sensitivity electrocardiograph (hsECG) Testing Device in Canada at the Canadian Cardiovascular Congress (CCC) in Vancouver.
The event will take place between 21 and 24 October.
The MyoVista hsECG is now available in Canada, where it received Health Canada Medical Device License for commercial sale.
The MyoVista hsECG was developed using Continuous Wavelet Transform mathematics and goes beyond conventional ECG technology with new metrics to detect repolarization abnormalities. This new capability enables physicians to detect diastolic dysfunction which is typically diagnosed using tissue Doppler echocardiography.
As an early manifestation of many types of heart disease, diastolic dysfunction has become a significant area of interest in cardiology. Coronary artery disease (CAD), hypertrophy, cardiomyopathy and valvular diseases are examples of diseases that will cause diastolic dysfunction.
The MyoVista hsECG, incorporates all of the capabilities of a full featured 12-lead resting ECG plus new proprietary informatics that assist in detecting diastolic dysfunction. Using machine learning, MyoVista hsECG technology detected diastolic dysfunction with 88 percent sensitivity, and 87 percent specificity, in a recent clinical trial at Mount Sinai Hospital in New York.*
"The MyoVista hsECG represents an exciting breakthrough in ECG technology," said Mark Hilz, Chief Executive Officer, HeartSciences. "We look forward to introducing this breakthrough technology to the Canadian market."
The device is also available across the European Union, where it received the CE (Conformité Européenne) Mark approval earlier this year. HeartSciences is also in the process of expanding distribution to Australia, the Middle East, Latin America and Asia-Pacific.
The device is not currently available for sale or use in the United States. HeartSciences expects to seek U.S. Food and Drug Administration clearance for MyoVista in 2018.
HeartSciences will be located at Booth #814 and will be demonstrating its breakthrough ECG technology, the MyoVista high sensitivity ECG (hsECG).