Medical technology company HeartFlow has received de novo approval from the US Food and Drug Administration for its FFRCT technology.
The non-invasive imaging technology has been developed for coronary artery disease, which provides insight on both the extent of the blockage, as well as its impact on blood flow, allowing physicians to develop a treatment plan that is right for a patient.
The FFRCT platform has been designed by integrating non-invasive imaging with computational fluid dynamics technology to produce detailed models of a patient’s cardiovascular anatomy.
With the approval, the platform will be evaluated in patients showing signs and symptoms of coronary artery disease, in conjunction with other clinical patient data, according to the company.
HeartFlow chairman and CEO John Stevens said: "FDA clearance of our FFRCT technology is a significant milestone that only further reinforces our belief in its potential to transform the way coronary artery disease is managed.
"Research on this technology began more than 20 years ago. We have continued to develop it with the goal of helping healthcare professionals identify the most appropriate care for each patient precisely, safely, efficiently and cost-effectively."
The approval was based on the clinical data from the firm’s NXT study, which demonstrated discriminatory ability to identify lesions that have the potential to impede blood flow when compared to coronary CT angiography alone.