FDA Grants 510(k) Clearance to AccurKardia's AccurECG™ Analysis System
Wednesday, July 12, 2023
AccurKardia, a medical technology company specializing in clinical-grade ECG interpretation software, has announced that its flagship product, the AccurECG™ Analysis System, has received FDA 510(k) clearance. This cloud-based and device-agnostic software platform provides fully automated electrocardiogram (ECG) interpretation, offering numerous benefits such as beat-by-beat analysis, detection of ectopic beats, heart rate measurement, and automated interpretation of 13 different heart rhythms.
The AccurECG™ Analysis System is designed to analyze data from various compatible ECG devices, including holter monitors, event recorders, and cardiac telemetry devices. With its automated output, clinicians can improve their efficiency and promptly treat patients, receiving results within minutes. The software is indicated for adults aged 22 and older.
This FDA clearance marks a significant milestone for AccurKardia, showcasing the advancement of remote cardiac care. The AccurECG™ solution aims to enhance accessibility and efficiency nationwide by providing a device-agnostic, medical-grade solution with transparent and explainable output. The software empowers healthcare providers with accurate and fast ECG interpretation, leading to improved clinical outcomes.
The AccurECG™ Analysis System offers customizable outputs and configurations, seamlessly integrates with existing clinical workflows, and ensures compliance with HIPAA regulations. Its cloud-based software-as-a-service (SaaS) model assists cardiac monitoring companies in improving their services and response time for analysis.
Based on clinical data reported to the FDA in a third-party clinical retrospective study, AccurECG™ has demonstrated an average aggregate sensitivity of approximately 96% and specificity of 99% in detecting arrhythmias across the 13 heart rhythms it covers. This clearance signifies a significant step forward in advancing remote cardiac care, enabling specialist-level ECG interpretation in communities and services that lack immediate access while streamlining workflow for busy clinical practitioners.