Medical technology company Evident Vascular has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Evident Vascular guidance system and Evident peripheral imaging catheters, which perform intravascular ultrasound (IVUS) exams during peripheral vascular interventions.
The platform combines flushless, plug-and-play catheters, hands-free voice control, and the company’s proprietary dynamic frequency control (DFC) technology, which adjusts imaging frequency to balance resolution and penetration across vessel sizes and imaging depths, according to the firm. Custom imaging electronics run real-time image processing on Nvidia accelerated computing, and the system includes an onboard AI workstation, Evident Vascular said.
Company officials said the clearance sets up further FDA submissions, and the firm plans to add AI features to the platform as clinical data build.
