Genetesis has announced that its flagship product, CardioFlux, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA) for the diagnosis of myocardial ischaemia and infarction in patients with symptoms suggestive of acute coronary syndrome.
CardioFlux leverages room temperature magnetometers to deliver non-invasive measurement of the heart’s naturally-generated magnetic fields.
“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 Robert Sokolowski, vice president of Clinical, Quality and Regulatory Affairs at Genetesis.
The FDA breakthrough devices programme 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 programme, the FDA provides interactive and timely communication during device development and throughout the review process.
“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, professor and director of clinical research, Department of Emergency Medicine, Wake Forest School of Medicine, Winston-Salem, USA. “The rapid approval process combined with reimbursement policy as part of this FDA Pathway will provide immediate access to this safe, non-invasive, and radiation-free diagnostic technology for our patients.”