CardioFlux MCG is a revolutionary imaging technology developed by Genetesis, Inc. to detect myocardial ischemia in individuals with coronary microvascular dysfunction (CMD).
The US Food and Drug Administration has designated it as a Breakthrough Device.
Historically, detecting CMD in clinical practice has been challenging due to a lack of sensitive and appropriate functional diagnostics and the outdated belief that CMD is predominantly benign and non-fatal.
In the United States alone, it is estimated that up to 4 million patients present with diagnostic evidence of ischemia despite the absence of occluded coronary arteries, a syndrome known broadly as INOCA.
Patients with CMD represent one of the most common subgroups within this population, and they have been demonstrated to have much greater risks of hospitalization and subsequent cardiovascular disease development.
The FDA's decision was based in part on preliminary findings from the MICRO trial, which intended to establish the use of non-invasive magnetocardiography (MCG) to identify myocardial ischemia in patients suspected of having CMD.
The Christ Hospital's participation in the MICRO trial greatly supported this work and facilitated the identification of the majority of participating patients.