November 22, 2021
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AI-guided arrhythmia diagnostic tool nets FDA clearance for use in pediatric cardiology
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Cardiologs announced it received 510(k) clearance from the FDA for use of its artificial intelligence-powered cardiac diagnostics platform in pediatric cardiology.
According to the press release, the expanded authorization was based on the results of an analysis of the company’s algorithm, which showed improved sensitivity over all major arrhythmias by 14% while reducing the number of false positives by 48%. Arrhythmia detection performance was similar across all age groups, including newborns and adolescents, regardless of the ECG recording device, according to the release.
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