Accurkardia has announced US Food and Drug Administration (FDA) 510(k) clearance and the commercial launch of its AccurECG analysis system (v2.0). AccurECG 2.0 builds on AccurKardia’s previously US FDA-cleared AccurECG platform, representing the next-generation evolution of its “enterprise-grade” electrocardiogram (ECG) interpretation system, as stated in a press release from the company.
With this milestone, the AccurECG platform has now secured two separate US FDA 510(k) clearances.
AccurECG represents Accurkardia’s US FDA-cleared Class II software as a medical device (SaMD) platform for fully automated, near-real-time ECG interpretation. It is intended to provide 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. Designed for cardiac monitoring companies, device makers, hospitals, and independent diagnostic testing facilities, AccurECG 2.0 provides device-agnostic interpretation that integrates directly into existing clinical workflows, delivering results “in minutes rather than days”, Accurkardia claims.
According to the company, AccurECG 2.0 addresses the challenges relating to ageing populations, and the proliferation of wearable technologies and remote monitoring, with three key capabilities:
- Ability to process high-volume ECG data streams with near-real-time speed and improved cost efficiency as volumes increase, enabling scalability
- Device agnosticism owing to a true hardware-neutral design that ingests data from patches, Holter monitors and other ECG devices without device-specific tuning or custom integration pipelines
- “Best-in-class” performance as per 99% accuracy seen across US FDA-cleared arrhythmia classifications, enabling lower technologist involvement and faster report generation
“US 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 chief executive officer (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 programmes without adding proportional clinical or operational burden.”
“With AccurECG 2.0, we are building on a clinically validated, US FDA-cleared foundation to further support cardiac monitoring workflows that depend on fast, consistent and high-quality interpretation,” added Nav Razvi, chief medical officer of Accurkardia. “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.”
