AccurKardia has announced that its flagship product, the AccurECG analysis system has been granted US Food and Drug Administration (FDA) 510(k) clearance.
AccurECG is a cloud-based, device-agnostic and fully automated electrocardiogram (ECG) interpretation software platform. The software includes 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.
AccurECG also 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. It is indicated for adults aged 22 and older.
Juan C Jiménez, CEO of AccurKardia, 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.”
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.”