Masimo smartSET Receives FDA Clearance for AFib and Opioid Depression Detection

Masimo's smartSET technology has received FDA 510(k) clearance for real-time detection of atrial fibrillation (AFib) and opioid-induced respiratory depression (OIRD). The AFib detection showed 97% sensitivity and 100% specificity in clinical validation. This AI-driven system integrates with existing pulse oximetry platforms to provide escalating notifications, aiming to improve patient safety by identifying these conditions silently developing between nursing rounds.