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PulseAI wins FDA clearance for smartwatch ECG analysis after study shows 92% fewer inconclusive results

Belfast-based PulseAI has secured United States regulatory clearance for artificial intelligence software designed to interpret electrocardiogram recordings from compatible wearable devices. A published study reported substantially fewer inconclusive results than the Apple Watch's native algorithm, but commercial adoption will depend on device integration, clinical workflows and evidence of real-world benefits.