YorLabs, a medical technology company developing next-generation intracardiac imaging solutions for electrophysiology (EP) and interventional cardiology (IC) procedures, has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its YorLabs intracardiac imaging system—a “first-of-its-kind”, zero-capex ultrasound platform designed to simplify workflow, reduce cost, and enhance procedural efficiency inside the cath lab.
The YorLabs system enables single-operator control and provides high-resolution, real-time imaging for a wide range of intracardiac procedures, according to the company. In a recent press release, YorLabs also notes that its compact, wireless system integrates seamlessly into cath labs, representing “a fundamental leap forward in how physicians visualise and guide therapy within the heart”.
“This clearance represents a major milestone for YorLabs and validates our vision to reimagine intracardiac imaging from the ground up,” said Gregory Casciaro, president and chief executive officer (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.”
YorLabs is planning a limited US market release of its intracardiac imaging system in 2026, followed by broader commercial rollout and clinical partnerships with leading centres of excellence in EP and IC.
