Clearance for Radius VSM
Masimo, a Danaher company, said the FDA has granted 510(k) clearance for an atrial fibrillation detection capability on its Radius VSM monitor. The feature sits on smartSET, the company's pulse oximetry platform, alongside a previously cleared, AI-enabled capability for detecting opioid-induced respiratory depression.
What the AFib feature does
The capability continuously analyses pulse waveform data to identify rhythms suggestive of AFib and to help clinicians judge when additional ECG or telemetry evaluation may be appropriate, according to the company. It does not replace ECG confirmation of AFib. In clinical validation testing, the feature showed sensitivity of 97% and specificity of 100%, Masimo said, comparing its classifications against those of three clinicians who reviewed concurrently collected ECG strips. The study included patients with and without AFib, among them some with other arrhythmias. The release states that AFib affects more than 10% of patients over age 65, often remains undiagnosed, and significantly increases long-term stroke risk.
OIRD detection
The previously cleared OIRD capability analyses oxygen saturation, pulse rate and perfusion index in real time to assess opioid overdose risk and issues escalating notifications on Radius VSM, the company said. The release cites figures showing that 1 in 10 surgical patients receiving opioids experience an opioid-related adverse event, and that 85% of postoperative OIRD events occur within the first 24 hours after surgery.
What executives said
Basil Matta, Masimo's chief medical officer, said respiratory compromise and cardiac arrhythmias often develop silently between routine rounds on general care floors, and that bringing pattern recognition into the pulse oximetry workflow helps clinicians see subtle physiological shifts earlier. Tim Benner, the company's president, said Masimo intends to continue expanding the smartSET platform to address other clinical needs.
