HeartSciences wins CE Mark, launches MyoVista ECG in the EU

August 17, 2017 By Sarah Faulkner

HeartSciences said today that its MyoVista high sensitivity electrocardiograph testing device won CE Mark and launched in Europe.

The Westlake, Texas.-based company’s device measures the heart’s energy per heartbeat using Continuous Wavelet Transform, a type of advanced signal processing that provides doctors with a detailed visual description of a cardiac cycle’s energy distribution.

Traditional resting ECG tech detects coronary artery disease less than 50% of the time, HeartSciences reported.

“Currently, there’s a significant diagnostic gap in detecting heart disease early, resulting in a burden on both patients and healthcare systems,” chairman Andrew Simpson said in prepared remarks. “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.”

In a 200-patient trial, MyoVista hsECG tech was able to detect cardiac dysfunction in a cardiac cycle’s resting phase with 88% sensitivity and 87% specificity, according to HeartSciences.

“Innovation is needed to advance front-line testing of patients for heart disease,” lead investigator Dr. Partho Sengupta said. “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 conventional ECG devices. The device combines informatics with traditional 12-lead resting ECG tracings and ECG interpretive analysis, HeartSciences said.

“It makes sense to use advanced signal processing to create a modern, low-cost, front-line tool to detect heart disease,” CEO Mark Hilz added. “While MyoVista represents a first-of-its-kind application to electrocardiographic testing, advanced signal processing has already enabled key imaging technologies such as computed tomography scans, magnetic resonance imaging, Doppler echocardiography and positron emission tomography scans.”

HeartSciences is reportedly planning to seek FDA clearance for MyoVista next year.

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