Genetesis, Inc. announced today that its flagship product, CardioFlux®, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome.
CardioFlux®, the most advanced commercially available magnetocardiograph (MCG), leverages highly sensitive room temperature magnetometers to deliver noninvasive measurement of the heart’s naturally-generated magnetic fields.
To meet the criteria for Breakthrough Designation, CardioFlux® demonstrated the potential for providing a safer, more precise, lower cost, and faster diagnosis for non-ST elevated myocardial infarction (NSTEMI) in the emergency room. Being a completely noninvasive, radiation-free diagnostic scan, requiring no pharmaceuticals or intravenous radioactive contrast agents, the 90-second CardioFlux test represents the most patient-centric solution for health care systems struggling to manage cost and quality of care for cardiac patients.
“We are very pleased with FDA’s vote of confidence that CardioFlux® has the potential to meet a significant unmet clinical burden in emergency rooms throughout the country. We are looking forward to working with the Agency in making this groundbreaking technology available to the millions of patients who present with symptoms suggestive of acute coronary syndrome, and to make the patient and clinical experience that much better, safer and affordable as a result,” said Dr. Robert Sokolowski, Vice President of Clinical, Quality and Regulatory Affairs at Genetesis.
The FDA Breakthrough Devices Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA provides interactive and timely communication during device development and throughout the review process. Genetesis looks forward to this accelerated collaborative dialogue with the FDA in the regulatory process leading to commercialization of CardioFlux® as a diagnostic modality.
“CardioFlux receiving Breakthrough Device Designation is an important step forward for patients presenting to Emergency Departments across the country with acute chest pain. Chest pain risk stratification continues to be one of our most expensive, radiation intensive, and time-consuming diagnostic burdens in the Emergency Department,” stated Simon A. Mahler, MD MS FACEP, Professor and Director of Clinical Research, Department of Emergency Medicine, Wake Forest School of Medicine. “The rapid approval process combined with reimbursement policy as part of this FDA Pathway will provide immediate access to this safe, noninvasive, and radiation-free diagnostic technology for our patients.”
In 2019, CardioFlux® was cleared by FDA for use as a general tool which non-invasively measures and displays the magnetic signals produced by the electric currents of the heart. This clearance heralded the formal entrance of CardioFlux®, and the announcement of this Breakthrough Device Designation can be viewed as a key step in enabling magnetocardiography for widespread clinical use, which Genetesis projects will take place in 2021.