PulseAI Receives the US FDA’s 510(k) Clearance for AI-Powered Arrhythmia Analysis Model for Wearables

Shots: PulseAI has received the US FDA’s 510(k) clearance for its AI-powered arrhythmia analysis model for wearables, enabling cloud-based automated ECG interpretation for compatible devices & software platforms In a prospective study of 296 participants published in Heart Rhythm, PulseAI’s algorithm improved AFib detection sensitivity while reporting a 92% reduction in inconclusive interpretations vs the Apple Watch’s native algorithm The clearance targets scalable review of patient-generated ECGs amid rising smartwatch adoption; Innovation Ulster Limited led PulseAI’s recent investment round alongside the Mortara Group Ref: PR Newswire  |   Image: PulseAI  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post PulseAI Receives the US FDA’s 510(k) Clearance for AI-Powered Arrhythmia Analysis Model for Wearables appeared first on PharmaShots.