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FDA grants breakthrough device status for Genetesis’ CardioFlux MCG

FDA grants breakthrough device status for Genetesis’ CardioFlux MCG
The MCG solution helps detect myocardial ischemia in patients suspected of having coronary microvascular disease.

The MICRO trial aimed to show the use of non-invasive MCG to diagnose myocardial ischemia in patients suspected to be suffering from CMD. Credit: StockSnap from Pixabay. Biomagnetic cardiac imaging solutions provider Genetesis has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its imaging solution, CardioFlux magnetocardiography (MCG).

The approval was awarded for a non-invasive diagnosis of myocardial ischemia using CardioFlux MCG.

MCG is a technique designed for the measurement of magnetic fields generated by electrical activity in the heart.

CardioFlux MCG can be used to detect myocardial ischemia in patients suffering from coronary microvascular disease (CMD). It is designed to provide advanced and high-tech imaging with patient comfort in mind.

Genetesis chief medical officer Dr Robert Takla said: “This milestone is a great step forward for patients who suffer from the impacts of CMD, many of whom do so unknowingly and it illustrates the FDA’s awareness that effective CMD diagnostics are largely inaccessible to most patients.”

The FDA has granted the breakthrough device status based on preliminary data from the MICRO trial.

The study endeavoured to show the use of non-invasive MCG to diagnose myocardial ischemia in patients suspected to have CMD.

The Christ Hospital helped identify most of the patients who participated in the trial.

Odayme Quesada, MICRO principal investigator and Christ Hospital Health Network’s Women’s Heart Centre medical director, said: “Many of the patients I see who I find to have CMD come to me with a history of past stress tests that either failed to show abnormalities or were largely inconclusive.

“If MCG works as intended and can lead to far earlier management of CMD, it’s exactly these patients who stand to benefit the most.”

In December 2020, CardioFlux received the first breakthrough device designation for the diagnosis of myocardial ischemia and infarction in patients who may be suffering from acute coronary syndrome.

April 14, 2023

https://www.medicaldevice-network.com/news/
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