Medical imaging company Genetesis has received Health Canada’s approval for CardioFlux Magnetocardiograph (MCG) to support the diagnosis of myocardial ischemia.
CardioFlux MCG is a zero-contact imaging technique. It assesses cardiac function by measuring tiny magnetic fields generated by the heart’s electrical activity.
This imaging modality helps identify signs of myocardial ischemia using 90 seconds of data acquisition.
According to the Ohio-based Genetesis, the process doesn’t require stress tests, injections, or radiation.
In December 2020, CardioFlux secured breakthrough device designation from the US Food and Drug Administration (FDA). The designation was for diagnosing myocardial ischemia and infarction in patients showing symptoms of acute coronary syndrome.
Last year, the medical imaging firm received a second breakthrough device designation from the FDA for CardioFlux MCG. This breakthrough status was granted to identify myocardial ischemia in patients who could be suffering from coronary microvascular disease (CMD).
With the latest clearance, Genetesis is seeking Canadian partners to promote early adoption and integration of MCG technology into the present standard care.
Genetesis CEO and co-founder Peeyush Shrivastava said: “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.
“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.”
The approval was based on results from multiple clinical trials by Genetesis. Key studies include MAGNETO and MICRO.
These trials demonstrated CardioFlux MCG’s ability to enhance diagnostic accuracy without using contrast agents, radiation, or stress-inducing pharmaceuticals.
The MAGNETO trial focused on patients with chest pain in the emergency department. It showed CardioFlux MCG’s effectiveness in identifying myocardial ischemia within the first four hours of presentation.
The MICRO study is said to be the first to assess the efficacy of CardioFlux MCG in detecting myocardial ischemia in patients with angina and confirmed non-obstructed arteries.
In July, Genetesis initiated the MICRO2 trial with the first patient enrolment at Ascension St. John Hospital in Michigan.
The study will assess the MCG’s ability to aid in the non-invasive diagnosis of CMD.
