AccurKardia, an ECG-led diagnostics software company, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for and launched its AccurECG analysis system v2.0.

AccurECG is the company’s FDA-cleared software as a medical device (SaMD) platform for automated, near real-time ECG interpretation. It offers beat-by-beat analysis, ventricular and supraventricular ectopic beat detection, heart rate measurement, and automated interpretation of 13 rhythm classifications, including atrial fibrillation, atrial flutter, and ventricular tachycardia, among others.

It’s designed for cardiac monitoring companies, device makers, hospitals, and independent diagnostic testing facilities (IDTFs). AccurECG 2.0 provides device-agnostic interpretation that integrates into existing clinical workflows, delivering results in minutes instead of days.

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.

It’s able to process high-volume ECG data streams with near-real time speed as improved efficiency as volumes increase, the company said. It boasts a hardware-neutral design that collects data from patches, Holters, and other ECG devices with device-specific tuning or custom integration pipelines.

“FDA clearance of AccurECG 2.0 is an important milestone for our company. This clearance positions us to accelerate go-to-market efforts in the first half of 2026,” said Juan C. Jiménez, co-founder and CEO of AccurKardia. “With this clearance we can support significantly higher ECG volumes with consistent, near real-time interpretation, allowing our customers to expand monitoring programs without adding proportional clinical or operational burden.”

According to the company, it performs with 99% accuracy across FDA-cleared arrhythmia classifications, enabling lower technologist involvement and faster generation of reports.

“With AccurECG 2.0, we are building on a clinically validated, FDA-cleared foundation to further support cardiac monitoring workflows that depend on fast, consistent, and high-quality interpretation,” said AccurKardia’s chief medical officer Dr. Nav Razvi. “As remote care continues to expand, software that improves efficiency while maintaining clinical standards can help extend access, especially in areas with limited specialist coverage.”

In October, the company begun a multi-center clinical pilot study of AK+ Guard, its artificial intelligence (AI)-powered technology that detects hyperkalemia using Lead I ECG.