SpectraWAVE, Inc., has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its X1™-FFR product.
This innovative, wire-free, drug-free solution provides physicians with fractional flow reserve (FFR) results from a single angiogram using a direct real-time angiography feed, removing the need for network-based DICOM file transfers.
The X1-FFR features AI-powered workflows, including automated vessel segmentation and frame suggestion, designed to simplify procedures and accelerate results.
It will be available as a software add-on to SpectraWAVE’s HyperVue Imaging System, creating the first platform to combine FDA-cleared angiogram-derived physiology with intravascular imaging.
By enabling accurate physiology assessment from a single angiogram, X1-FFR aims to improve workflow efficiency and reduce procedural complexity in cardiac catheterisation labs.
HyperVue with X1-FFR represents a significant advance in non-invasive physiology measurement, offering a faster and safer alternative to traditional pressure wire-based methods.
This marks SpectraWAVE’s fifth FDA clearance in just over two years, reinforcing its commitment to innovation and improved patient outcomes in interventional cardiology.
