The US Food and Drug Administration (FDA) has granted Masimo clearance for atrial fibrillation (AFib) detection via Radius VSM, further expanding the Danaher subsidiary’s wearable vital signs monitor beyond individual measurements to support earlier evaluation and intervention for irregular heart rhythms.
Photoplethysmography (PPG) AFib continuously analyses pulse waveform data captured by Radius VSM using pattern recognition and artificial intelligence (AI)-based signal analysis of light-based optical sensing technology. Powered by Masimo’s underlying pulse oximetry sensor platform, smartSET, the function is designed to help clinicians determine when additional ECG or telemetry evaluation may be appropriate for patients displaying irregular heart rhythms.
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PPG AFib’s clearance follows Masimo’s FDA clearance for opioid-induced respiratory depression (OIRD) detection, also via Radius VSM, in June 2026.
Masimo’s president, Tim Benner, said: “For more than three decades, Masimo has expanded what clinicians can expect from pulse oximetry. With smartSET, we are bringing intelligent sensing and AI-enabled detection to the bedside – building on our signal-processing expertise to turn continuous monitoring data into meaningful clinical insight.
“Looking ahead, we intend to continue expanding the smartSET platform to address other critical clinical needs. This is how we advance innovation – by focusing on the information clinicians need to care for patients,” Benner continued.
According to a GlobalData market model, Masimo held the lion’s share of the global pulse oximeter market in 2025 at 21.3%, and a US market share of 23.1%. Meanwhile, the global market for pulse oximetry systems, which are medical devices used for measuring oxygen saturation levels in the blood and heart rate, is growing at a CAGR of around 4.2% and is projected to reach a valuation of around $2.2bn in 2035, as per GlobalData analysis.
Masimo was acquired by Danaher for $9.9bn in June, with the deal positioned to strengthen the life science conglomerate’s offering in the acute care space. Upon the deal’s announcement in February, Danaher CEO Rainer Blair said the acquisition would “greatly strengthen” its diagnostics franchise.
The sale of Masimo brought a challenging chapter in the company’s history to a close. In recent years, the company has been involved in a patent dispute against Apple over blood oxygen meters. Apple was accused of copying methods to use light sensors for the measurement of biomarkers. Siding with Masimo, a California court ordered Apple to pay Masimo $634m in damages in relation to patent infringement in November 2025.
AFib is a common heart condition that affects more than 10% of patients over 65 and can lead to stroke and heart failure if left unaddressed. Treatment options for the condition have expanded in recent years with the advent of pulsed-field ablation (PFA) – a catheter-based treatment wherein high-energy electrical pulses are used to destroy abnormal heart tissue.
First movers in this space include Boston Scientific, Medtronic, and Johnson and Johnson (J&J). According to GlobalData analysis, the PFA market is growing at a compound annual growth rate (CAGR) of around 16.9% and is forecast to reach a $16.4bn valuation in 2035.
