FDA grants 510(k) clearance to AccurKardia’s AccurECG Analysis System

12 Jul 2023
www.nsmedicaldevices.com
Clinical Result
The cloud-based AccurECG is a device-agnostic, and fully automated ECG interpretation software platform that can help cardiac monitoring companies expand access and provide remote care AccurKardia’s AccurECG system gets FDA clearance. (Credit: Towfiqu barbhuiya on Unsplash) Medical technology company AccurKardia has received the US Food and Drug Administration (FDA) 510(k) clearance for its lead product, AccurECG Analysis System. The cloud-based AccurECG is a device-agnostic and fully automated electrocardiogram (ECG) interpretation software platform that can help cardiac monitoring companies expand access and provide remote care. Indicated for adults aged 22 and older, the AccurECG software offers beat-by-beat analysis, ventricular/supraventricular ectopic beat detection, and measurements of heart rate. It also provides an automated interpretation of 13 different heart rhythms like sinus tachycardia, sinus bradycardia, atrial fibrillation, and atrial flutter. Additionally, the software offers Lead II analysis of data generated from compatible ECG devices with wet electrodes like holter monitors, event recorders, and/or cardiac telemetry devices. According to AccurKardia, AccurECG’s fully automated output increases the efficiency of clinicians’ review processes and enables fast patient treatment with results available in minutes. AccurKardia CEO Juan Jiménez said: “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 revolutionise 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.” In addition, the system’s benefits include customisable outputs and configurations as well as a seamless, HIPAA-compliant interface with existing clinical workflows. Its cloud-based SaaS model is said to benefit cardiac monitoring businesses by providing a solution that can enhance their customer service and turnaround time for analysis. In comparison to conventional computational interpretation products on the market, the ECG interpretation software helps improve clinical outcomes by providing rapid analysis and lowering false positives, AccurKardia claimed. In a third-party clinical retrospective analysis, AccurECG has shown an average aggregate sensitivity and specificity of about 96% and 99%, respectively, in arrhythmias detection across its covered 13 heart rhythms, as per the data submitted to the FDA.
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