Intracardiac Imaging System Gets FDA 510(k) Clearance

Oct. 24, 2025 —YorLabs, Inc., a medical technology company developing next-generation intracardiac imaging solutions for electrophysiology (EP) and interventional cardiology (IC) procedures, recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's YorLabs Intracardiac Imaging System — a zero-capex ultrasound platform designed to simplify workflow, reduce cost, and enhance procedural efficiency inside the cath lab.