Masimo smartSET Receives FDA Clearance for AFib and OIRD Detection
Masimo's smartSET technology has received FDA 510(k) clearance, enabling pulse oximetry devices to detect atrial fibrillation (AFib) and opioid-induced respiratory depression (OIRD) in real-time. The AFib detection showed 97% sensitivity and 100% specificity in clinical validation. This advancement aims to enhance patient safety by providing escalating notifications on wearable devices, addressing conditions that often develop silently between nursing rounds.
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