Newly announced Canadian license marks the first approval of any kind of MCG device in Health Canada history
Genetesis, Inc., a leader in the field of magnetocardiography (MCG), today announced that Health Canada has approved the CardioFlux Magnetocardiograph with a license for use by physicians to aid in the diagnosis of myocardial ischemia.
“Our team is thrilled by the achievement of this milestone, and it certainly represents the culmination of several years of work conducted in partnership with some incredible investigators and study teams,” said Genetesis CEO and Co-Founder Peeyush Shrivastava. “This is our first foray beyond the US, and we’re excited to partner with physicians in Canada to improve both patient outcomes AND patient experience.”
Approval was based on the submission of evidence from multiple clinical trials conducted by Genetesis, including both the MAGNETO (suspected acute coronary syndrome in the Emergency Department) and MICRO (suspected coronary microvascular dysfunction in patients with angina but confirmed non-obstructed arteries) studies. Submitted data provided compelling evidence of CardioFlux MCG’s ability to enhance diagnostic accuracy without the need for contrast agents, radiation, or pharmaceutical-induced stress.
The MAGNETO trial examined CardioFlux MCG’s ability to identify myocardial ischemia in patients presenting with chest pain in the Emergency Department (with the notable advantage of being able to provide disposition within a patient’s first four hours of presenting). The MICRO trial was the first known study in MCG history to examine MCG’s efficacy in detecting myocardial ischemia in patients with angina who have confirmed non-obstructed arteries, a condition formally known as ANOCA.
CardioFlux MCG is a zero-contact imaging modality that assesses cardiac function by examining the tiny magnetic fields produced by the heart’s regular electrical activity to identify electrophysiological signs of myocardial ischemia. Notably, CardioFlux MCG requires just 90 seconds of data acquisition and does not require any stress, injections, or radiation.
While approved by Health Canada, CardioFlux MCG is not yet accessible to a vast majority of Canadians. Genetesis is working diligently to identify Canadian partners interested in early adoption and integration of MCG technologies into the current standard of care.
