Research & Development
Cardiologs announces FDA 510(k) clearance for cardiac diagnostics AI platform for paediatric use
23 November 2021 -

Medical technology company Cardiologs reported on Monday the receipt of US Food and Drug Administration (FDA) 510(k) clearance for its AI-powered cardiac diagnostics platform for paediatric cardiology based on an analysis of its improved deep learning algorithm.

Based on 20 million EKG recordings, the company used the new model to evaluate a global sample of 10,000 EKG readings from patients in various age groups. The updated algorithm improved average sensitivity over all major arrhythmias by 14% while reducing the number of false positives by 48%.

The company added that the new data shows improved deep learning algorithm performs equally across all age groups, enabling more patients to benefit from the company's cardiac diagnostics AI platform.

A policy statement published online recommended that all children be screened for the risk of sudden cardiac arrest (CA) or sudden cardiac death (SCD) at a minimum every three years. An increasing number of physicians are combining clinical expertise with AI-assisted analysis to improve detection for children and teens with abnormal heart rhythms, which can lead to earlier intervention and better outcomes.