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

News | Cardiac Diagnostics

September 15, 2022 - Happitech has announced the launch of its FastStart Research app. The Amsterdam-based digital ...

Home September 15, 2022
Home
Feature | Cardiac Diagnostics | by Kelly Patrick

Like most healthcare markets, the diagnostic cardiology market has had a bumpy ride in recent years. The COVID-19 ...

Home August 23, 2022
Home
Feature | Cardiac Diagnostics | By Adam Saltman, MD, PhD

Before opining on the future of cardiac health, I think it’s important to define what “cardiac health” actually is. If ...

Home May 04, 2022
Home
News | Cardiac Diagnostics

January 31, 2022 — Scientists have developed an artificial intelligence (AI) system that can analyze eye scans taken ...

Home January 31, 2022
Home
News | Cardiac Diagnostics

November 10, 2021 — Abbott released new global market research from its Beyond Intervention initiative, the company’s ...

Home November 10, 2021
Home
Feature | Cardiac Diagnostics | By Dave Fornell, DAIC Editor

October 29, 2021 — A new guideline for the evaluation and diagnosis of chest pain was released this week that provides ...

Home October 29, 2021
Home
News | Cardiac Diagnostics

October 4, 2021 – Nanowear, a hospital-at-home and remote diagnostic platform that used proprietary wearable cloth ...

Home October 04, 2021
Home
News | Cardiac Diagnostics

September 28, 2021 — Biotricity Inc., a medical diagnostic and consumer healthcare technology company, has developed a ...

Home September 28, 2021
Home
News | Cardiac Diagnostics

July 29, 2021 — A recent clinical study from Overlake Medical Center utilizing the Bardy Diagnostics Carnation ...

Home July 29, 2021
Home
News | Cardiac Diagnostics

July 1, 2021 — The U.S. Food and Drug Administration (FDA) has cleared the Angel Medical Systems Inc. second-generation ...

Home July 01, 2021
Home
Subscribe Now