Cardiologs’ AI receives FDA clearance for paediatric use

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Cardiologs announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to use its AI-powered cardiac diagnostics platform for paediatric cardiology.

The expanded authorisation was granted based on an analysis of the company’s improved deep learning algorithm, which first received FDA clearance in 2017. The new model, now supported by more than 20 million ECG recordings, was used to evaluate a global sample of 10,000 ECG readings from patients in various age groups. Results showed that the updated algorithm improved average sensitivity over all major arrhythmias by 14% while reducing the number of false positives by 48%. In addition, arrhythmias detection performance was similar across all age groups, including newborns and adolescents, regardless of the ECG recording device.

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

AI is growing in all areas of medicine and is considered the next frontier in paediatric cardiology.  A recent policy statement published online in June 2021 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.

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

Cardiologs is being purchased by Royal Philips. The transaction, which is subject to customary closing conditions, is expected to be completed in the coming months.


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