AccurKardia, a medical technology company delivering ECG interpretation software, announced that its flagship product, the AccurECG Analysis System, has been granted U.S. FDA 510(k) clearance. AccurECG is a cloud-based, device-agnostic and fully automated electrocardiogram (ECG) interpretation software platform.

AccurECG software provides several benefits, such as beat-by-beat analysis, ventricular/supraventricular ectopic beat detection, heart rate measurement and automated interpretation of 13 different heart rhythms including sinus tachycardia, sinus bradycardia, atrial fibrillation and atrial flutter, among others. It provides Lead II analysis of data obtained from compatible ECG devices with wet electrodes such as holter monitors, event recorder and/or cardiac telemetry devices. The fully automated output of AccurECG improves clinicians’ review efficiencies and enables prompt treatment of patients, with results delivered in minutes. It is indicated for adults aged 22 and older.

“Receiving FDA 510(k) clearance is a significant milestone for us and we are extremely proud of what we have built. AccurECG is set to revolutionize remote cardiac care, making it more accessible and efficient across the Nation,” says Juan C. Jiménez, CEO of AccurKardia. “By providing a device-agnostic, medical-grade solution with explainable output and no ‘black box’ approach, we aim to empower healthcare providers with accurate, fast, efficient and transparent ECG interpretation.”

The system’s key benefits range from customizable outputs and configurations to seamless integration with established clinical workflows in an HIPAA-compliant manner. Its cloud-based SaaS model assists cardiac monitoring companies by delivering a solution that can improve their service and response time for analysis.

AccurKardia’s offering helps improve clinical outcomes delivering a prompt analysis while minimizing false positives. Based on clinical data reported to FDA in a third-party clinical retrospective study, AccurECG has demonstrated an average aggregate sensitivity and specificity of approximately 96% and 99%, respectively, in detecting arrhythmias across its covered 13 heart rhythms.

“Our team at AccurKardia is incredibly proud to achieve FDA 510(k) clearance for the AccurECG Analysis System,” says Nav Razvi, MD, chief medical officer of AccurKardia. “This clearance signifies a great stride forward in advancing remote cardiac care. The AccurECG solution can enable specialist-level ECG interpretation in communities and services that do not have ready access, as well as increasing the efficiency of workflow for busy clinical practitioners.”

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