Cardiologs’ AI Software Gets FDA’s 510(k) Clearance for Pediatric Use

Cardiologs has received an expanded 510(k) clearance from the FDA for its artificial intelligence-based diagnostic software for use in pediatric cardiology.

The FDA granted the additional clearance based on an analysis of Cardiologs’ improved deep learning algorithm, which first received the agency’s marketing clearance in 2017.

The updated software was used to evaluate 10,000 electrocardiogram (ECG) readings from patients in various age groups. The new algorithm had a 14 percent better average sensitivity for all major arrhythmias, while reducing the number of false positives by 48 percent.

Arrhythmia detection was similar in all age groups, including newborns and adolescents, regardless of the ECG recording device, the company said.