Evident Vascular has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Evident Vascular Guidance System (EVGS), an intravascular ultrasound (IVUS) platform designed for peripheral vascular interventions. The system combines high-resolution ultrasound imaging, proprietary image-processing technology and computing capabilities powered by NVIDIA. The FDA issued its substantial equivalence determination on 28 October 2026 under submission K261648. The device is classified as Class II and was found substantially equivalent to the previously cleared iLab Polaris Multi-Modality Guidance System (K210889). The EVGS is intended for ultrasound examination of intravascular pathology in...