Masimo Wins FDA Clearance for AFib Detection on Radius VSM
Image
Irvine – October 17, 2026 -- Masimo, a Danaher company, has received FDA 510(k) clearance for atrial fibrillation (AFib) detection on its Radius VSM monitor. The feature showed 97% sensitivity and 100% specificity in clinical validation testing, according to the company.
The AFib capability joins the company's previously cleared, AI-enabled detection of opioid-induced respiratory depression (OIRD) under the smartSET platform. Masimo describes smartSET as the next evolution of its Signal Extraction Technology (SET) pulse oximetry, which draws on more than 35 years of signal-processing development.