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.
Validation study benchmarked PPG AFib classifications against three clinicians' ECG reviews
The smartSET photoplethysmography (PPG) feature continuously analyzes pulse waveform data to identify rhythms suggestive of AFib. It is meant to help clinicians decide when additional electrocardiogram (ECG) or telemetry evaluation is appropriate. It does not replace ECG confirmation.
The validation study compared the feature's classifications with those of three clinicians who reviewed concurrently collected ECG strips as ground truth. Cohorts included patients with AFib, patients without it, and some with other arrhythmias. The underlying data is held on file by Masimo and has not been published.
The clearance covers patients 18 and older. The feature is cleared to identify rhythms suggestive of AFib over a monitoring period to supplement the decision for AFib screening, and it is not intended to replace traditional diagnosis or treatment.
AFib affects more than 10% of patients over 65 and often goes undiagnosed
Masimo cites research indicating that AFib affects more than 10% of patients over age 65 and significantly raises long-term stroke risk. Dr. Basil Matta, Chief Medical Officer, said respiratory compromise and cardiac arrhythmias often develop silently between routine rounds on general care floors.
OIRD detection analyzes three parameters in real time to flag opioid overdose risk
The OIRD capability continuously analyzes oxygen saturation (SpO2), pulse rate (PR) and perfusion index (Pi). When it identifies patterns associated with OIRD, Radius VSM generates escalating notifications.
Masimo cites published research showing that 1 in 10 surgical patients receiving opioids experience an opioid-related adverse event. It also cites research showing that 85% of postoperative OIRD events occur within the first 24 hours after surgery.
Masimo plans to extend smartSET to additional clinical needs
Tim Benner, President of Masimo, said the company intends to keep expanding smartSET to address other critical clinical needs. Both capabilities run within a traditional pulse oximetry workflow. Healthcare organizations can schedule an evaluation through their Masimo representative.