Evident Vascular Receives FDA Clearance for High-Fidelity AI Powered IVUS Imaging Platform

Evident Vascular Guidance System introduces high-fidelity imaging and efficient procedural workflow

SAN JOSE, Calif.--(BUSINESS WIRE)--Evident Vascular, Inc., today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Evident Vascular^® Guidance System and Evident^® peripheral imaging catheters. The Evident Vascular Guidance System is intended for ultrasound examination of intravascular pathology during peripheral vascular interventions.

The Evident platform is designed to transform the IVUS imaging experience by bringing together high-fidelity imaging, purpose-built AI, and workflow without disruption. Evident’s proprietary flushless, plug-and-play catheters, intuitive user interface, and hands-free voice control are designed to support procedural efficiency.

“FDA clearance marks an important milestone for Evident and the physicians who believed in this platform from our company’s inception,” said Howard Rosen, Chief Executive Officer and Co-Founder of Evident Vascular. “We engineered the entire imaging architecture to deliver the image fidelity physicians need in a system that is both intuitive and easy to use.”

Conventional high-definition imaging is commonly associated with image resolution and ultrasound center frequency. However, center frequency alone cannot describe IVUS image quality as it is only one part of the imaging equation. Evident’s high-fidelity imaging takes a whole-system approach, integrating broad frequency bandwidth, advanced transducer design, and advanced signal processing. At the core of this architecture is Evident’s proprietary DFC™ technology, which provides dynamic frequency control to optimize imaging.

“The vessel-edge clarity and consistency across the field of view are remarkable. By optimizing resolution and penetration across a range of vessel sizes and imaging depths, Evident’s technology provides detailed images for physicians to consider when measuring vessels, making decisions about therapy, and assessing procedural results,” said Eric A. Secemsky, MD, Director of Vascular Intervention at Beth Israel Deaconess Medical Center.

Evident’s groundbreaking platform pairs custom imaging electronics with real-time image processing on NVIDIA accelerated computing. Evident is a member of the NVIDIA Inception program for startups. Evident’s proprietary AI workstation and full stack of advanced software are designed to enable AI directly at the point of care. As clinical experience and data grow, Evident intends to expand the platform’s AI capabilities, introducing new features designed to further enhance imaging, workflow, and the overall user experience.

“Evident was founded on the belief that high-fidelity imaging and seamless workflow, paired over time with responsibly developed AI, can help advance IVUS toward precision therapy guidance,” said Justin Klein, MD, JD, Managing Partner at Vensana Capital and a founder and Board Director of Evident Vascular. “This clearance establishes an important foundation for further FDA submissions to enable that long-term vision. As imaging data contribute to a continuously growing evidence base, our ultimate goal will be to provide physicians with a platform that enables easy image interpretation and informs treatment decisions to provide optimal patient outcomes.”

About Evident Vascular

Evident Vascular, Inc., is a medical technology company advancing intravascular ultrasound (IVUS) through high-fidelity imaging and streamlined procedural workflow. For more information, visit www.evidentvascular.com and follow Evident Vascular on LinkedIn.

Evident Vascular, Evident and DFC are trademarks of Evident Vascular, Inc. Vensana Capital is a trademark of Vensana Capital Management, LLC.

This press release contains “forward-looking statements” concerning the development of Evident Vascular’s products, the benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. The Evident Vascular system and catheters are not available for sale in the United States or other jurisdictions. These statements are made as of the date of this press release. Actual results may vary. Evident Vascular undertakes no obligation to update any forward-looking statements for any reason.