#United States #FDA Clearance #Beaverton #YorLabs #Intracardiac Imaging

YorLabs Receives FDA 510(k) Clearance for Intracardiac Imaging System

YorLabs, Inc., located in Beaverton, Oregon, has made headlines with its recent announcement regarding the FDA's approval of its innovative Intracardiac Imaging System. This system is groundbreaking, as it is the first ultrasound platform that eliminates the need for high upfront capital expenditures. Through this exciting development, YorLabs aims to transform the landscape of electrophysiology (EP) and interventional cardiology (IC) procedures.

The new system, specifically designed for use within catheterization laboratories (cath labs), enables single-operator control while delivering high-resolution, real-time imaging for a variety of intracardiac procedures. The compact and wireless nature of this technological breakthrough allows it to integrate seamlessly into existing cath lab environments, representing a significant advancement in how physicians visualize and guide therapeutic interventions inside the heart.

"Achieving this clearance is an essential milestone for YorLabs and validates our ambition to revolutionize intracardiac imaging from its very foundation," stated Gregory D. Casciaro, President and CEO of YorLabs. He emphasized that traditional imaging systems used in cath labs have been expensive, unwieldy, and poorly integrated into procedural workflows. In contrast, YorLabs offers a solution that boasts the same imaging performance as these traditional systems but in a user-friendly, more accessible format.

Meeting the Growing Demand for Innovative ICE Procedures

The demand for intracardiac echocardiography (ICE) has significantly increased as electrophysiology and structural heart procedures expand at an impressive rate. Medical professionals are finding that having greater visualization during transseptal access, ablation, and left atrial appendage closure procedures is crucial for improving patient safety and precision. YorLabs' imaging platform is tailor-made to meet this growing demand by providing advanced imaging performance without the burden of capital investments.

The main features of the YorLabs system include:

• - Zero CapEx Deployment: This feature eliminates the need for large upfront investments, making the technology accessible to a broader range of medical facilities.
• - Single-Operator Control: This design minimizes cognitive load and enhances team coordination during medical procedures, allowing for improved efficiency.
• - Zero-Footprint Integration: The software-defined platform is designed to fit within existing cath labs without requiring additional space.
• - High-Definition Intracardiac Imaging: The system provides real-time visualization that aids doctors in maneuvering for complex heart interventions confidently.

YorLabs plans to launch a limited market release in the United States in 2026, followed by a broader rollout. This initiative will coincide with clinical partnerships with top-tier centers of excellence in electrophysiology and interventional cardiology to enhance clinical practices.

About YorLabs

Privately held, YorLabs is committed to advancing medical technology. With headquarters in Beaverton, Oregon, and manufacturing capabilities in Carlsbad, California, the company specializes in developing advanced imaging systems that simplify complex medical procedures, cut costs, and ultimately improve patient outcomes. The proprietary zero-footprint platform designed by YorLabs is set to redefine the way heart imaging is conducted, ensuring that precision therapy becomes accessible to every cath lab.

For more information, visit www.yorlabs.com.