A real-time, cloud-based ECG analytics software can now be rolled out to remote cardiac care, after the US Food and Drug Administration (FDA) granted 510(k) clearance to AccurKardia’s technology.
The software, called AccurECG, uses data obtained from ECG devices to provide beat-by-beat analysis, heart rate measurement, ectopic beat detection, and can provide insights on different heart rhythms such as tachycardia, bradycardia, and atrial fibrillation. The automated output of clinical insights means results are ready within minutes.
The New York-based company, which raised $2.7m in seed funding in June, says the software uses a combination of artificial intelligence (AI) and non-AI-based algorithms to provide the analytics.
The product is available as software as a service (SaaS), meaning it can be rolled out to cardiac monitoring companies and integrated as part of an established clinical workflow. The New York-based company is also targeting telehealth service providers. The cloud-based nature of the software facilities patients who require remote monitoring for heart conditions.
Research conducted on patients, submitted to the FDA as part of regulatory clearance, using the technology demonstrated a sensitivity of 96% and a specificity of 99% in detecting arrhythmias.
A report by GlobalData estimates the global cloud services and infrastructure market in healthcare will be $40bn by 2026, with SaaS revenues contributing $16bn to the market.
Dr Nav Razvi, Chief Medical Officer of AccurKardia said: “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.”
Juan C. Jiménez, AccurKardia’s CEO added: “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.”
