Explore VerAvanti’s Common FAQs

VerAvanti expects to submit its first 510(k), for the Luce system, in 2027. The timing of FDA clearance depends on FDA's review. Registrations outside the United States will follow U.S. clearance.

The Early Access Program lets clinicians, research institutions and prospective partners register interest in VerAvanti's technology and in future clinical studies. Any use of a VerAvanti device in patients takes place only within an approved clinical study. Registering does not provide access to an investigational device.

By joining, you’ll gain exclusive early access to VerAvanti’s breakthrough Scanning Fiber Endoscope—before it hits the market. You’ll be among the first to: Use pre-commercial SFE units in your real-world cases, giving you a clinical edge Collaborate directly with our expert clinical and technical teams for tailored support Participate in cutting-edge research, case studies, and data collection that can boost your reputation Receive early training and insights, preparing you to lead when the product launches commercially This is your chance to shape the future of vascular imaging and stay ahead of the curve.

We kindly ask our participants to: Use the device in appropriate investigational or observational settings. Provide timely and detailed feedback on usability and performance. Collaborate with our team as needed, such as assisting with study design, data sharing, or providing clinical insights. Your input is essential to refining the technology and ensuring it meets real-world clinical needs.

Eligible participants include: Interventional cardiologists and vascular surgeons Clinical researchers and academic hospitals Distributors or strategic partners preparing for market entry Final eligibility will be confirmed by our assessment team upon submission.

Yes. We will support your academic publications, case reports, and collaborative research efforts. Our team will assist you in navigating regulatory requirements to ensure your work aligns with compliance standards.

IVUS and OCT are established tools that image the vessel wall beside the catheter in cross-section. VerAvanti's systems are designed to show, in color, what lies directly ahead of the catheter. They are being developed to complement IVUS and OCT, not to replace them.

The first focus is the peripheral and coronary arteries. The scanning fiber technology has been demonstrated in research settings in other parts of the body, including the airways and the gastrointestinal tract. Those are future applications.

Yes. Angioscopy was tried in the 1990s and did not succeed, largely because of probe size, image quality and the need to clear blood. VerAvanti's systems are about one millimeter in diameter and designed for real-time color imaging. Our development and clinical program is designed to show whether that is enough to succeed where angioscopy did not.

Today, operators reconstruct what lies ahead from side views and contrast shadows. Forward-viewing imaging is designed to let them see it directly. Whether that improves outcomes will be established through clinical studies.

No. Like other optical imaging, VerAvanti's systems need a brief flush to clear blood from the view. Imaging through blood is a research direction, not a product feature.

Senso is AI-enabled software in development for the VerAvanti console, designed to help the operator interpret what the catheter shows. It is a tool for the interventionalist, not a substitute for clinical judgment.

Our first product, Luce, is being prepared for a 510(k) submission. Wider clinical use will follow clearance and the clinical studies that support specific uses.