Fully automated ECG analysis system gains FDA 510(k) clearance
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Key takeaways:
- Automated ECG interpretation system gains FDA clearance for detection of 13 arrhythmias.
- The system is indicated for ECG analysis in patients aged 22 years and older.
AccurKardia announced it received FDA 510(k) clearance for its cloud-based, device-agnostic and automated ECG analysis software for adults aged 22 years and older.
The system (AccurECG) is designed to provide beat-by-beat analysis, ventricular/supraventricular ectopic beat detection, heart rate measurement and automated interpretation of 13 different heart rhythms, with results delivered in minutes, according to a company press release.
The system also provides lead II analysis of data from compatible ECG devices with wet electrodes such as Holter monitors, event recorder and/or cardiac telemetry devices, according to the release.
In addition, the system demonstrated an average aggregate sensitivity of approximately 96% and specificity of approximately 99% in detecting arrhythmias, according to the release.
“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,” Nav Razvi, MD, chief medical officer of AccurKardia, said in the release. “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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