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)–#AI—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.

AccurECG is AccurKardia’s FDA-cleared Class II software as a medical device (SaMD) platform for fully automated, near real-time ECG interpretation. AccurECG provides 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 (IDTFs), AccurECG 2.0 provides device-agnostic interpretation that integrates directly into existing clinical workflows, delivering results in minutes rather than days.

As cardiac data volumes explode due to aging demographics and the proliferation of wearables and remote monitoring, clinical teams face an unsustainable backlog. AccurECG 2.0 addresses these challenges with three key capabilities:

• Architected for scale: Able to process high-volume ECG data streams with near real-time speed and improved cost efficiency as volumes increase.
• Device agnostic: A true hardware-neutral design that ingests data from patches, Holters, and other ECG devices without device-specific tuning or custom integration pipelines.
• Best-in-class performance: 99 percent accuracy across FDA-cleared arrhythmia classifications, enabling lower technologist involvement and faster report generation.¹

“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.”

Dr. Nav Razvi, chief medical officer of AccurKardia, added, “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. 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.”

About AccurKardia

AccurKardia is 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 globally. With initial applications in cardiology, the company offers transformative, cloud-based diagnostic tools, including AccurECG, an FDA-cleared Class II software as a medical device (SaMD), for fully automated, near real-time ECG interpretation. AccurKardia is also advancing an investigational pipeline of ECG-based biomarkers, including AK+ Guard for hyperkalemia risk assessment using Lead I ECG and AK-AVS for aortic stenosis risk assessment, both of which have received FDA Breakthrough Device Designation.

Disclaimer:

For detailed technical AccurECG 2.0 requirements, relevant disclosures, and approved indications for use, please refer to the U.S. FDA 510(k) K252361 summary and product labeling.

AK-AVS and AK+ Guard are currently for research use only and have not been cleared or approved by the U.S. FDA for use in the United States. This technology is under development and intended solely for investigational purposes.

1. Based on clinical data reported to FDA in a retrospective study for cleared arrhythmia indications.

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