AccurKardia announced today that the FDA granted 510(k) clearance for its cloud-based electrocardiogram (ECG) interpretation software.
The AccurECG analysis system, a device-agnostic, fully automated platform, offers a wide range of benefits in ECG interpretation. It features beat-by-beat analysis, ventricular/supraventricular ectopic beat detection and heart rate measurement. The system offers automated interpretation of 13 different heart rhythms, including sinus tachycardia, sinus bradycardia, AFib and atrial flutter.
AccurKardia said that AccurECG provides Lead II analysis of data obtained from compatible ECG devices with wet electrodes. These include Holter monitors, event recorders and/or cardiac telemetry devices. Its fully automated output improves clinicians’ review efficiencies and enables the prompt treatment of patients. AccurKardia says it delivers results in just minutes.
Other benefits include customizable outputs and configurations, plus seamless integrations with established clinical workflows. AccurECG’s cloud-based SaaS model assists cardiac monitoring companies with an offering capable of improving service and response time.
AccurKardia said clinical data demonstrated an average aggregate sensitivity and specificity of approximately 96% and 99%, respectively, in detecting arrhythmias across its covered 13 heart rhythms.
FDA clearance covers adults aged 22 and older, according to a news release
“Receiving FDA 510(k) clearance is a significant milestone for us and we are extremely proud of what we have built,” said AccurKardia CEO Juan Jiménez. “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.”