US magnetocardiography (MCG) company Genetesis Inc announced on Friday that it has received approval from Health Canada for its CardioFlux Magnetocardiograph (CardioFlux MCG) with a licence for use by physicians to support the diagnosis of myocardial ischemia.
CardioFlux MCG received approval based on the submission of evidence from various clinical trials carried out by the company, including both the MAGNETO (suspected ACS in the ER) and MICRO (suspected CMD in patients with angina but confirmed non-obstructed arteries) studies. Submitted data provided evidence of CardioFlux MCG's ability to improve diagnostic accuracy without the requirement for contrast agents, radiation or pharmaceutical-induced stress.
According to Genetesis, CardioFlux MCG, a zero-contact imaging modality, evaluates cardiac function by assessing the tiny magnetic fields produced by the heart's regular electrical activity to identify electrophysiological signs of myocardial ischemia. It needs 90 seconds of data acquisition and does not require any stress, injections or radiation.
Although CardioFlux MCG is approved by Health Canada, it is not yet accessible to the vast majority of Canadians. Genetesis is looking to identify Canadian partners interested in early implementation and integration of MCG technologies into the current standard of care.
Genetesis' CardioFlux Magnetocardiograph receives Health Canada approval
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