We are actively advancing through the U.S. FDA review process, with clearance anticipated in the second half of 2026. Efforts to obtain CE marking for the European Union and United Kingdom will begin shortly thereafter. For markets outside North America and Europe, we expect to initiate local regulatory approvals in early 2027.

The SFE provides forward-looking, true-color, real-time imaging. OCT and IVUS capture grayscale side-view frames that require interpretation. SFE makes visualization intuitive by showing what’s directly ahead, helping identify plaque rupture, calcified nodules, and true lumen pathways more easily and accurately.

VerAvanti’s Early Access program offers qualified clinicians, researchers, and commercial partners an opportunity to evaluate our SFE before regulatory clearance. It’s designed for those looking to solve critical challenges in vascular imaging — from poor visualization in CTOs and strokes to workflow inefficiencies and study limitations.

Participants gain early hands-on use, contribute feedback to shape the final product, and position themselves as early adopters of a single-use, radiation-free technology built to improve outcomes and reduce procedural risk.

The commercial version requires saline flushing for clear images. A next-gen model using infrared wavelengths to see through blood is under development. It's a top R&D priority and expected to be a major leap forward once commercialized.

SFE is currently being tested across neurovascular, gastroenterology, ENT, pulmonology, urology, dental, and fluorescence-guided imaging. The initial commercial focus is intravascular, but the tech is being validated for full-body applications from head to toe.

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.

Yes, angioscopy existed in the 1990s but failed due to poor resolution, patient discomfort, and bulky probes. VerAvanti’s version solves these issues with sub-1mm fiber optics, MEMS-driven spiral scanning, no radiation, and clear imaging that works in real time.

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.

It eliminates the need to mentally reconstruct anatomy from side-views and shadows. Instead of interpreting indirect signals, clinicians can directly see what lies ahead. This improves precision, reduces the risk of procedural errors, and speeds up decision-making.

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.

The commercial version requires saline flushing for clear images. A next-gen model using infrared wavelengths to see through blood is under development. It's a top R&D priority and expected to be a major leap forward once commercialized.

Yes. The SFE enables clinicians to plan stent deployment, confirm positioning, and evaluate healing over time. It shifts imaging from static to dynamic, helping catch issues that might be missed using legacy systems.

Current saline flushing may limit use in some cases due to temporary blood displacement. However, ongoing R&D into an infrared-capable SFE aims to eliminate this need altogether, allowing visualization through blood without impacting downstream oxygenation.

While detailed analysis remains under wraps, the company is building software capabilities at the console level to interpret imaging, categorize findings, and potentially integrate with AI in future iterations to assist with diagnosis and navigation.

The company is moving toward FDA clearance and has already invested over $40M in R&D, protected by 50+ patents. The intravascular market is the first beachhead, with expansion planned as regulatory milestones are met and manufacturing scales.