News | ECG | August 22, 2017

HeartSciences Announces CE Mark and European Launch of MyoVista High Sensitivity ECG

Low-cost cardiac screening advancement integrates wavelet signal processing technology to improve early detection of heart disease

HeartSciences Announces CE Mark and European Launch of MyoVista High Sensitivity ECG

Just as a Doppler radar color image shows the energy of a storm, MyoVista provides physicians a detailed visual image of the energy distribution during the cardiac cycle.

August 22, 2017 — HeartSciences announced the European launch of the MyoVista high sensitivity electrocardiograph (hsECG) Testing Device, developed in response to the global unmet need for effective, low-cost, front-line screening of cardiac disease in both symptomatic and asymptomatic patients. MyoVista measures the heart's energy during each heartbeat using a type of advanced signal processing known as Continuous Wavelet Transform (CWT).

Advanced signal processing has revolutionized early detection and predictive accuracy in other applications like weather forecasting. Just as a Doppler radar color image shows the energy of a storm, MyoVista provides physicians a detailed visual image of the energy distribution during the cardiac cycle. 

Electrical, structural and coronary artery disease (CAD) comprise the three main categories of heart disease, but existing ECG technology, which functions essentially in the same way as when first introduced in 1903, has limited effectiveness in detecting structural and CAD. Even though it is the front-line screening tool used by physicians to detect heart disease, conventional resting ECG technology detects CAD less than 50 percent of the time, which leaves a large number of patients who have heart disease undiagnosed. As a result, current healthcare guidance does not recommend use of ECG testing on asymptomatic patients.

"Currently, there's a significant diagnostic gap in detecting heart disease early, resulting in a burden on both patients and healthcare systems," said Andrew Simpson, chairman, HeartSciences. "We believe MyoVista hsECG could play an important role in achieving the preventative treatment ambitions of many healthcare systems as well as help reduce unnecessary healthcare expenditures."

The application of advanced signal processing technology can assist in closing the diagnostic gap by providing a low-cost, front-line tool that can assist in the early detection of cardiac dysfunction. During the validation trial, MyoVista hsECG technology detected cardiac dysfunction in the resting (diastolic) phase of the cardiac cycle with 88 percent sensitivity and 87 percent specificity. The 200-patient trial assessed the presence of left ventricular diastolic dysfunction.

"Innovation is needed to advance front-line testing of patients for heart disease," said Partho P. Sengupta, M.D., chief of cardiology and chair of cardiac innovation at West Virginia University, and lead investigator on a MyoVista clinical trial. "High sensitivity ECG technology holds significant promise for improving the detection of heart disease."

MyoVista hsECG uses the same 12-lead, at-rest testing protocol as traditional ECG devices on the market today to help facilitate easy adoption for clinical staff. The difference is that MyoVista is a single test that provides healthcare practitioners with unique informatics, as well as conventional 12-lead resting ECG tracings and conventional ECG interpretive analysis. In combination, these assist identification of cardiac dysfunction related to CAD and structural disease, as well as identifying arrhythmias.

MyoVista hsECG is available across the European Union, where it received the CE Mark approval for commercial sale. The company is also in the process of expanding distribution to Australia, the Middle East, Latin America, Asia-Pacific and Canada. 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.

For more information: www.heartsciences.com

Related Content

High Intensity Exercise in Teenagers Could Ward Off Heart Disease

Ultrasound image of the carotid artery. Lines in yellow were used to determine arterial diameter and stretching before and following exercise.

News | Cardiac Diagnostics | July 16, 2018
New research published in Experimental Physiology has indicated potential differences in heart health benefits of...
News | Cardiac Diagnostics | June 14, 2018
A team of researchers says it has linked sensitivity to an allergen in red meat to the buildup of plaque in the...
The blood of patients with familial chylomicronemia syndrome (FCS) can appear milky in color (lipemic) due to the buildup of fat in their body. Image courtesy of Akcea Therapeutics.

The blood of patients with familial chylomicronemia syndrome (FCS) can appear milky in color (lipemic) due to the buildup of fat in their body. Image courtesy of Akcea Therapeutics.

 

Feature | Cardiac Diagnostics | May 07, 2018 | Steven D. Freedman, M.D., Ph.D.
 
Male Triathletes May Be Putting Their Heart Health at Risk
News | Cardiac Diagnostics | January 09, 2018
Competitive male triathletes face a higher risk of a potentially harmful heart condition called myocardial fibrosis,...
ERT Acquires iCardiac Technologies
News | Cardiac Diagnostics | December 19, 2017
ERT recently announced it has acquired iCardiac Technologies, a provider of centralized cardiac safety and respiratory...
New Study Suggests Protein Could Protect Against Coronary Artery Disease

Patients with no obstructed blood flow in the coronary arteries had higher levels of CXCL5 (blue) compared to patients with moderate levels (green) or lower levels (yellow) of CXCL5, who had increased severity of coronary obstructions (indicated by the arrows). Credit: Schisler lab

News | Cardiac Diagnostics | December 07, 2017
December 7, 2017 — The buildup of plaque in the heart’s arteries is an unfortunate part of aging.
E-cigarettes Most Likely to be Used by Alcohol Drinkers and Former Cigarette Smokers, at American Heart Association (AHA), #AHA2017.
News | Cardiac Diagnostics | December 06, 2017
December 6, 2017 — Electronic cigarettes are more frequently used by people who recently quit smoking and alcohol dri
Lack of sleep may cause heart disease in older women. American heart Association, #AHA2017
News | Cardiac Diagnostics | December 06, 2017
December 6, 2017 — Older women who do not get enough sleep were more likely to have poor cardiovascular health, accor
Overlay Init