Arterys has received FDA 510(k) clearance for its software for cloud-based medical image visualization and quantification. This platform provides the first comprehensive visualization and quantification of cardiac 4D flow and cardiac function available to physicians in clinical settings.
The software can be integrated into clinical practice to deliver comprehensive cardiac MR imaging. The company previously received FDA clearance for the software’s 4D flow visualization feature. With the company’s cloud-based platform, providers can collect and process very large data sets in real-time—which translates into fast, comprehensive cardiac exams.
The software can analyze the blood flow to the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded MR images in 4D. Its data has been tested and validated on images acquired from both 1.5 Tesla (T) and 3T MR scanners. Aortic disease, complex congenital heart disease, shunts and collateral vessels, and valvular disease are some of the main clinical applications for the software.
Following FDA clearance, the company intends to launch the product in the United States via a partnership with GE Healthcare as the ViosWorks 4D product.
“We are thrilled to gain FDA clearance for visualization and quantification of cardiovascular MR images,” says Fabien Beckers, CEO of Arterys. “The entire Arterys team is committed to providing technology that is valuable to clinicians and also improves their workflow. We believe that our 4D Flow software represents a significant advance in medical imaging, making scans more accessible, useful, and practical for patients and medical professionals.”
For more information about this product clearance, visit Arterys.