AccurKardia Secures FDA 510(k) Clearance of and Launches AccurECG 2.0
Newly cleared AccurECG 2.0 is enterprise-grade, device-agnostic ECG interpretation platform designed for scale, accelerated turnaround, and flexible customer integrations.
NEW YORK–(BUSINESS WIRE)–AccurKardia, an ECG-led diagnostics software company focused on transforming ECG data into a more powerful diagnostic tool and broad biomarker to improve patient outcomes and save lives, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the commercial launch of its AccurECG™ Analysis System (v2.0) (K252361) (“AccurECG 2.0”). AccurECG 2.0 builds on AccurKardia’s previously FDA-cleared AccurECG platform, representing the next-generation evolution of the company’s enterprise-grade ECG interpretation system. With this milestone, the AccurECG platform has now secured two separate FDA 510(k) clearances.
