FDA Clears YorLabs Intracardiac Imaging System, Introducing a Zero-CapEx Solution for Cath Labs

The U.S. Food and Drug Administration has cleared a new ultrasound system from YorLabs, Inc., marking a notable step forward in intracardiac imaging technology for electrophysiology and interventional cardiology procedures.

The YorLabs Intracardiac Imaging System is described as the first of its kind—a compact, wireless, zero-capital-expenditure (zero-CapEx) platform built to simplify workflow, lower costs, and increase procedural efficiency in catheterization labs. Unlike traditional systems that require significant hardware investment, YorLabs’ software-based approach offers high-resolution, real-time imaging without the need for bulky or expensive equipment.

According to the company, the system enables single-operator control and integrates easily into existing cath lab setups. The platform provides detailed intracardiac visualization to guide a range of procedures, representing what the firm calls a major leap in procedural imaging.

“This clearance represents a major milestone for YorLabs and validates our vision to reimagine intracardiac imaging from the ground up,” said Gregory D. Casciaro, President and CEO of YorLabs. “For decades, cath labs have relied on legacy imaging systems that are expensive, cumbersome, and poorly integrated into procedural workflows. Our platform delivers the same performance as capital-intensive systems, but in a simpler, smarter, and more accessible way.”

Responding to the Growth of ICE-Guided Interventions

Electrophysiology and structural heart procedures are among the fastest-growing areas in modern interventional medicine, with global procedure volumes expanding at double-digit rates each year. The use of intracardiac echocardiography (ICE) has surged as clinicians seek better visualization and precision during interventions such as transseptal puncture, ablation, and left atrial appendage closure.

The YorLabs system is designed to meet this rising demand. By combining advanced imaging performance with a flexible, capital-free model, the company aims to make ICE guidance more accessible and efficient across a wider range of hospitals and heart centers.

Among its key capabilities, the YorLabs system features:

• Zero CapEx deployment, removing large upfront equipment costs

• Single-operator control for improved workflow and reduced cognitive load

• Seamless, zero-footprint integration with existing cath lab systems

• High-definition, real-time intracardiac imaging for improved guidance during complex procedures

YorLabs intends to launch the platform through a limited U.S. market release in 2026, with broader commercial availability to follow. The company also plans to form partnerships with leading electrophysiology and interventional cardiology centers to advance clinical adoption.

With FDA clearance now secured, YorLabs positions its technology as a disruptive alternative to legacy imaging systems—one designed to make intracardiac imaging simpler, more cost-effective, and better aligned with the evolving demands of modern cardiac care.