Sam Brusco, Associate Editor07.11.23
AccurKardia, a clinical-grade electrocardiogram (ECG) interpretation software company, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its flagship AccurECG analysis system. AccurECG is a cloud-based, device-agnostic, automated ECG interpretation software platform.
AccurECG offers 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 also provides Lead II analysis of data gathered from compatible ECG devices with wet electrodes like holter monitors, event recorders, and/or cardiac telemetry devices.
Its fully automated output helps improve review efficiencies and allows prompt treatment, with results generated in minutes. AccurECG is indicated for people aged 22 and over.
Juan C. Jiménez, CEO of AccurKardia, told the press, “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. 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 software touts customizable inputs and configurations, as well as integrations with clinical workflows in a HIPAA-compliant way. Its cloud-based SaaS model helps cardiac monitoring firms with a solution that can boost the service and response time for analysis.
Based on clinical data reported to FDA in a third-party clinical retrospective study, AccurECG has shown average aggregate sensitivity and specificity of about 96% and 99%, respectively, in detecting arrhythmias across its covered 13 heart rhythms.
Dr. Nav Razvi, chief medical officer of AccurKardia, said, "Our team at AccurKardia is incredibly proud to achieve FDA 510(k) clearance for the AccurECG Analysis System. 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."
AccurECG offers 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 also provides Lead II analysis of data gathered from compatible ECG devices with wet electrodes like holter monitors, event recorders, and/or cardiac telemetry devices.
Its fully automated output helps improve review efficiencies and allows prompt treatment, with results generated in minutes. AccurECG is indicated for people aged 22 and over.
Juan C. Jiménez, CEO of AccurKardia, told the press, “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. 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 software touts customizable inputs and configurations, as well as integrations with clinical workflows in a HIPAA-compliant way. Its cloud-based SaaS model helps cardiac monitoring firms with a solution that can boost the service and response time for analysis.
Based on clinical data reported to FDA in a third-party clinical retrospective study, AccurECG has shown average aggregate sensitivity and specificity of about 96% and 99%, respectively, in detecting arrhythmias across its covered 13 heart rhythms.
Dr. Nav Razvi, chief medical officer of AccurKardia, said, "Our team at AccurKardia is incredibly proud to achieve FDA 510(k) clearance for the AccurECG Analysis System. 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."