YorLabs Completes First Clinical Procedure Using FDA-Cleared Zero-CapEx Intracardiac Imaging System

BEAVERTON, Ore., Jan. 12, 2026 /PRNewswire/ -- YorLabs, Inc., a medical technology company pioneering next-generation intracardiac imaging solutions for electrophysiology (EP) and interventional cardiology (IC), today announced the successful completion of the first clinical procedure using its FDA 510(k)-cleared YorLabs Intracardiac Imaging System. The procedure marks the first real-world clinical use of YorLabs' Zero-CapEx imaging platform following U.S. Food and Drug Administration clearance. The YorLabs platform currently provides high-resolution 2D intracardiac echocardiography (ICE) imaging, and the company is actively developing 4D ICE capabilities as part of its product roadmap.

The procedure was conducted at Oregon Health & Science University (OHSU), one of the nation's leading academic medical centers, by Saket Sanghai, M.D., and Firas Zahr, M.D., using the YorLabs system to provide real-time intracardiac visualization during an atrial fibrillation ablation procedure. The system delivered high-resolution imaging under single-operator control and integrated seamlessly into the existing cath lab workflow without requiring additional capital expenditures.

"This first procedure represents an important step forward for how intracardiac imaging can be delivered in the cath lab," said Dr. Sanghai. "The system was intuitive to use, fit naturally into our workflow, and provided the image quality needed to confidently guide the procedure."

"Having access to high-quality intracardiac imaging without the constraints of traditional capital equipment is compelling," added Dr. Zahr. "This new platform has the potential to broaden access to ICE-guided procedures while reducing complexity for physicians and care teams."

The YorLabs Intracardiac Imaging System is the first Zero-CapEx ultrasound platform designed specifically to simplify workflow, reduce cost, and enhance procedural efficiency inside the cath lab. Its compact, wireless, software-defined architecture enables single-operator control and high-resolution, real-time imaging across a broad range of intracardiac procedures.

"This milestone demonstrates that our platform performs as designed in the clinical environment," said Gregory D. Casciaro, President and CEO of YorLabs. "Completing our first procedure at a leading academic medical center like OHSU so soon after FDA clearance reinforces our belief that intracardiac imaging can be simpler, more accessible, and better aligned with how physicians practice today."

Advancing Access to ICE-Guided Procedures

The use of intracardiac echocardiography (ICE) continues to expand rapidly across electrophysiology and structural heart procedures, driven by the need for improved visualization, safety, and procedural precision. YorLabs' Zero-CapEx is designed to meet this growing demand by delivering advanced imaging performance without the cost, complexity, or infrastructure burden of legacy capital systems.

YorLabs plans a limited U.S. market release in 2026, followed by broader commercial rollout and clinical partnerships with leading centers of excellence in electrophysiology and interventional cardiology.

About YorLabs

YorLabs is a privately held medical technology company headquartered in Beaverton, Oregon, with manufacturing and distribution operations in Carlsbad, California. The company develops advanced intracardiac imaging and guidance systems that simplify complex procedures, reduce cost, and improve patient outcomes. Its proprietary platform redefines how imaging is delivered inside the heart—making precision therapy accessible in every cath lab.

For more information, visit www.yorlabs.com.

SOURCE YorLabs