The no-capital-expenditure ultrasound platform is designed to simplify workflow, reduce cost, and enhance procedural efficiency inside the cath lab.
YorLabs Inc, a medical technology company specializing in intracardiac imaging solutions for electrophysiology and interventional cardiology procedures, announced that the US Food and Drug Administration has granted 510(k) clearance for the company’s YorLabs Intracardiac Imaging System, a no-capital-expenditure ultrasound platform designed to simplify workflow, reduce cost, and enhance procedural efficiency inside the cath lab.
The YorLabs system enables single-operator control and is designed to provide high-resolution, real-time imaging for various intracardiac procedures. Its compact, wireless system integrates into cath labs.
“This clearance represents a major milestone for YorLabs and validates our vision to reimagine intracardiac imaging from the ground up,” says Gregory D. Casciaro, president and CEO of YorLabs, in a release. “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.”
Meeting the Growing Demand for ICE-Guided Procedures
Electrophysiology and structural heart procedures are among the fastest-growing segments in interventional medicine, with global procedure volumes expanding at double-digit annual rates, according to a release from the company, which notes that the use of intracardiac echocardiography has surged as clinicians seek greater visualization, safety, and precision during transseptal access, ablation, and left atrial appendage closure procedures.
The YorLabs system offers:
- Zero CapEx deployment — eliminates large upfront capital purchases
- Single-operator control — reduces cognitive load and streamlines team coordination during procedures
- Zero-footprint integration — software-defined platform fits into existing cath lab environments
- High-definition intracardiac imaging — delivers real-time visualization to guide complex interventions with confidence
YorLabs plans a limited US market release in 2026, followed by broader commercial rollout and clinical partnerships with leading centers of excellence in electrophysiology and interventional cardiology.
ID 23512641 © Tsiumpa | Dreamstime.com
