FDA clears AI-powered cardiac platform for pediatric patients

Cardiologs, a Paris-based healthcare technology company, has been cleared by the FDA to use its AI-powered cardiac diagnostics platform for pediatric cardiology patients.

According to the company, the expanded use authorization was given based on analysis of the firm’s latest deep learning algorithm, which originally received FDA clearance in 2017.

"The fact that our algorithm continues to improve and is proven to deliver clinically consistent results across all age groups means clinicians can now utilize our ground-breaking technology with the utmost confidence even in children under the age of 18," Yann Fleureau, Cardiologs CEO and co-founder, said in a prepared statement.

In the same statement, Cardiologs said that the new model was used to evaluate a global sample of 10,000 electrocardiogram readings from patients in numerous age groups. The updated algorithm improved average sensitivity over all major arrhythmias by 14% while reducing the number of false positives by 48%.

Furthermore, arrhythmia detection performance was comparable across all age groups, including newborns and adolescents.

"We are proud to build the future of cardiology diagnosis with AI-assisted analysis," Fleureau said. "Gaining expanded FDA clearance validates Cardiologs commitment to helping clinicians better manage patients suffering from cardiac arrhythmia disorders."

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