HeartSciences gets green light to sell next-gen ECG in EU

MyoVista (Image: HeartSciences)

HeartSciences has started selling its MyoVista electrocardiograph (ECG) in Europe after picking up a CE mark. The device is designed to enable early detection of artery disease by visualizing energy distribution during cardiac cycles.

Traditional ECGs detect and display the electrical signals the heart produces when it beats. The low cost and safety of the test made it a go-to option for doctors. But the shortcomings of ECGs have seen organizations including U.K. cost watchdog NICE recommend against their use in certain situations. ECGs are particularly poor at detecting structural and ischemic heart disease.

HeartSciences, formerly known as Heart Test Laboratories, thinks its device high-sensitivity ECG (hsECG) is a better option in these situations, Rather than just display a line, the device maps myocardial energy levels in a similar way to how weather forecasts show the energy of storms. HeartSciences claims this results in a test with 88% sensitivity and 87% specificity for cardiac dysfunction.  

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These results have encouraged HeartSciences to aim MyoVista at a gap in heart disease pathways.

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

HeartSciences foresees MyoVista giving healthcare systems a quick way of diagnosing cardiac dysfunction without paying much more per test than they do for traditional ECGs. That would enable doctors to assess whether a patient has a health problem that needs attention without using more expensive and invasive procedures, such as nuclear stress tests and invasive angiograms, that are typically reserved for diagnosed patients. 

Fueled by the $12 million financing it completed in January and guided by the regulatory VP it hired in April, HeartSciences has secured clearance to sell the device in Europe. The next step is to file for clearance to sell the device in the U.S. HeartSciences plans to approach the FDA next year.