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- October 24, 2025

YorLabs Announces FDA 510(k) Clearance of its Zero-CapEx Intracardiac Imaging System

BEAVERTON, Ore., Oct. 24, 2025 /PRNewswire/ — YorLabs, Inc., a medical technology company pioneering next-generation intracardiac imaging solutions for electrophysiology (EP) and interventional cardiology (IC) procedures, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s 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.

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