Genetesis said that the FDA has cleared its biomagnetic cardiac imaging platform intended for chest pain triage.
The Mason, Ohio-based company said it designed its CardioFlux magnetocardiography (MCG) device to enable rapid, noninvasive and accurate chest pain triage.
Unlike MRI, magnetocardiography passively records the body’s functional electromagnetic activity without pulsing or emitting any magnetic fields. CardioFlux uses optically pumped magnetometers, eliminating the need for liquid helium cooling, which the company said was previously an obstacle to wide-scale commercial adoption of magnetocardiography. CardioFlux data is sent securely to the company’s Faraday analytical cloud platform, from which physicians can review the functional imaging data and access web services, and hospitals can leverage an integrated billing service.
An investigational study using a prototype CardioFlux device was completed at Ascension St. John Hospital’s emergency department observation unit in Detroit and presented by Dr. Margarita Pena, medical director of the department’s clinical decision unit as a plenary session of the American College Emergency Physicians 2018 Scientific Assembly.
“Throughout the study, it became evident that there is great potential for magnetocardiography and CardioFlux to positively impact the clinical workflow of patients presenting to the ED with chest pain or anginal equivalents, which represent nearly 10 million emergency room visits a year,” Pena said in a prepared statement from Genetesis.
“Building on the initial investigational study at Ascension St. John Hospital, we see the value in magnetocardiography along with the 20 years of clinical investigation on the use of MCG and the diagnosis of myocardial ischemia and coronary artery disease,” added Dr. Edouard Daher, director of the hospital’s cardiac catheterization laboratory. “Ascension St. John is now collaborating with several sites to launch the largest multi-center study using MCG, to date.”
West Virginia University’s Heart and Vascular Institute is also participating in the study on the broader applicability to cardiovascular and coronary artery disease.
“These are major steps forward by the team at Genetesis,” said John Rice, chair of the company’s board of directors. “Achieving these clinical and commercial milestones enables delivery of an end-to-end medical device and cloud computing platform focused on improving patient care and reducing costs.”
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