Back to News and Events November 22, 2021

Cardiologs’ AI Receives 510(k) Clearance for Pediatric Use

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

PARIS and Boston, Mass. – November 22, 2021 Cardiologs announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to use its AI-powered cardiac diagnostics platform for pediatric cardiology. 

The expanded authorization 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 EKG recordings, was used to evaluate a global sample of 10,000 EKG 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 EKG 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 utilize our ground-breaking 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 pediatric 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. 

This is the latest in a string of recent milestones for Cardiologs. Earlier this month, the company announced the results of a new study that showed its AI model outperforms the Apple Watch ECG algorithm (ECG 1.0 App) in detecting atrial arrhythmias (AAs). News also broke that Cardiologs is being purchased by healthcare technology leader Royal Philips, which plans to use its global footprint to accelerate the adoption of Cardiologs’ technology worldwide.

About Cardiologs

Cardiologs is a medical technology company committed to transforming cardiac diagnostics using medical-grade artificial intelligence and cloud technology.  Developed in partnership with leading physicians, the Cardiologs Holter Platform empowers clinicians worldwide to deliver expert cardiac care faster and more efficiently.  CE-Marked and FDA cleared for detection of 14 cardiac arrhythmias, the Cardiologs Holter Platform is built on a growing database of more than 20 million ECG recordings and is supported by a number of clinical publications.

Media Contact:
Andrea LePain
eMedia Junction