FDA Clears Emerging Intracardiac Ultrasound System

Amid increasing demand for transseptal access, ablation and left atrial appendage closure procedures, the Intracardiac Imaging System, a zero-capex ultrasound-based platform, has garnered 510(k) clearance from the Food and Drug Administration (FDA).

YorLabs, the developer of the Intracardiac Imaging System, emphasized that the modality is a viable cost-effective alternative to older ultrasound platforms in the cath lab setting. The Intracardiac Imaging System facilitates high-definition intracardiac echocardiography through a service-based model that alleviates concerns about large upfront capital expenditures, according to YorLabs.

The company noted other attributes of the Intracardiac Ultrasound System include seamless integration of the ultrasound-based software platform into existing cath lab settings and single-operator control, which streamlines team coordination for complex procedures involving intracardiac echocardiography.

"This clearance represents a major milestone for YorLabs and validates our vision to reimagine intracardiac imaging from the ground up," said Gregory D. Casciaro, the 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."