Masimo Receives FDA Clearance for AFib Detection on Radius VSM

Irvine, Calif. – Masimo, a Danaher company and a specialty diagnostics solutions innovator, announced FDA 510(k) clearance for an atrial fibrillation (AFib) detection capability on its Radius VSM device. This capability, combined with its previously cleared AI-enabled opioid-induced respiratory depression (OIRD) detection, expands Masimo's smartSET™ technology beyond individual measurements. It uses advanced pattern recognition and AI signal analysis to help clinicians identify physiological changes associated with significant clinical events.

The smartSET™ platform represents an evolution of Masimo's SET® pulse oximetry, aiming to provide clinical insights rather than just measurements. The AFib and OIRD features are designed to help clinicians detect rhythms suggestive of AFib and physiological patterns associated with OIRD, supporting earlier evaluation and intervention. The goal is to identify respiratory compromise and cardiac arrhythmias sooner, even between routine checks.

The new AFib capability continuously analyzes pulse waveform data to identify rhythms suggestive of AFib, assisting clinicians in determining when further evaluation, such as an electrocardiogram (ECG) or telemetry, may be warranted. It is important to note that this feature provides an indication for further clinical evaluation and does not replace ECG confirmation of AFib. In clinical validation testing, the AFib capability demonstrated 97% sensitivity and 100% specificity.

The OIRD capability analyzes oxygen saturation (SpO₂), pulse rate (PR), and perfusion index (Pi) in real time to assess opioid overdose risk. The system is designed to generate escalating notifications on the Radius VSM and aims to provide clinicians with peace of mind by identifying patterns associated with OIRD. Masimo intends to continue expanding the smartSET™ platform to address other critical clinical needs.