Medical imaging company SpectraWAVE has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its X1-FFR single angiogram derived physiology software.

X1-FFR generates physiology results from a single angiogram taken via a direct, real-time angiography feed. This removes the need for network-based DICOM file management and transfer delays, according to the company.

The software’s artificial intelligence (AI) also automates vessel segmentation and frame suggestion to simplify and hasten FFR results. Hailed as the first platform combining an FDA-cleared angiogram-derived physiology with intravascular imaging, X1 comes as a software add-on to the company’s HyperVue imaging system.

X1-FFR is also wire- and drug-free. Michael C. Kim, MD, director of the cardiac cath labs at Lenox Hill Hospital and director of interventional cardiology in the Western Region of Northwell Health in NYC, explained that because physiology is necessary for percutaneous coronary intervention (PCI) outcomes, replacing invasive pressure wires with non-invasive angiogram-derived physiology is better and safer for patients.

Dr. Kim also said that despite the advancement of angio-derived FFR over the past few years, workflow and user variability have been a challenge for current tech needing multiple angiograms.

“SpectraWAVE’s X1-FFR technology represents the next stage in angio-derived physiology requiring only one view per vessel to derive an accurate FFR value,” he told the press. “Our experience in clinical study cases has achieved many results in less than one minute. We are big believers in this technology, and we predict widespread usage not only within our large health system but nationally and internationally with the goal of identifying appropriate lesions for revascularization.”

SpectraWAVE CEO Eman Namati, Ph.D. explained that since the company’s HyperVue intravascular imaging tech is a comprehensive product already on the market, combining it with the X1 software creates a unique central hub for cath labs with both angiogram-derived physiology and imaging in one platform.

“By focusing on one vessel at a time, X1 can achieve accurate results from a single angiogram, while layering in state-of-the-art AI augmentation unlocks a number of key workflow benefits for customers, resulting in rapid and simple procedures,” Dr. Namati said. “The clinical experience to date has been fantastic, and we’re excited to begin providing this to our customers and their patients. This marks our fifth FDA clearance in just over two years, reflecting our continued commitment to technological advancement to support patient outcomes in the cath lab.”