Masimo's hospital finger sensor can now flag possible AFib, after an FDA clearance

Masimo on Saturday, Oct. 17, 2026, said it received FDA 510(k) clearance for an atrial fibrillation detection feature on its Radius VSM wearable monitor, part of a pulse-oximetry platform it calls smartSET.

The most-used sensor in the hospital is the little clip on your finger, and Masimo is turning it from a number into a lookout. On a general ward, where nurses check vitals every few hours, a sensor that's already on the patient and starts nudging "this rhythm looks like AFib" or "this breathing pattern looks like an opioid problem" could catch trouble between rounds. The caveats are real: 100% specificity on unpublished company data is a number to hold loosely, and every new alarm competes with alarm fatigue. But this is the kind of AI in medicine that actually ships: small, specific, cleared, and bolted onto hardware hospitals already own.

On Oct. 17, 2026, Masimo — which describes itself as "a Danaher company" — announced FDA 510(k) clearance for an atrial fibrillation, or AFib, detection capability on its Radius VSM wearable monitor. A 510(k) is the FDA's clearance path for a device the agency judges similar enough to one already on the market. AFib is an irregular heartbeat. Radius VSM is a wearable hospital monitor. Those lines are Masimo's.

smartSET is Masimo's name for the platform: the new pulse-waveform AFib feature plus a previously cleared, AI-enabled opioid-induced respiratory depression feature, shortened to OIRD. That means the software watches for breathing trouble tied to opioid pain drugs. smartSET sensors unlock both features, which Masimo says are currently available only on Radius VSM wearable devices. Masimo describes the platform as using "advanced pattern recognition and AI signal analysis." Those lines are Masimo's.

The AFib feature continuously analyzes pulse waveform data from the pulse oximeter — the light sensor already on a finger that measures oxygen — to identify rhythms suggestive of AFib, so clinicians can decide when an electrocardiogram, or ECG, or a telemetry check is warranted. Telemetry is the continuous heart-rhythm strip hospitals already use. Masimo says the feature is an indication for further evaluation and does not replace ECG confirmation. It is not a diagnosis on its own.

Masimo-reported validation: 97% sensitivity and 100% specificity, comparing the feature's classifications against three clinicians reviewing concurrently recorded ECG strips. Sensitivity here means how often it caught AFib when the clinicians said AFib was there. Specificity means how often it stayed quiet when they said it was not. The study included patients with and without AFib, including some with other arrhythmias. The source is "Masimo data on file" — not a published study. Sample size is not disclosed. Those figures are Masimo's, not independent or peer-reviewed results.

The OIRD feature analyzes oxygen saturation, pulse rate and perfusion index in real time to spot patterns associated with opioid-induced respiratory depression, and raises escalating alarms on Radius VSM. Oxygen saturation is the share of blood carrying oxygen. Perfusion index is a pulse-oximeter reading of how strongly blood is flowing at the sensor. Those lines are Masimo's.

Masimo cites that AFib affects more than 10% of patients over 65 and often goes undiagnosed, and that 1 in 10 surgical patients receiving opioids has an opioid-related adverse event. Those figures are Masimo's citations.

Masimo chief medical officer Dr. Basil Matta said: "When a patient deteriorates on a general care floor, respiratory compromise and cardiac arrhythmias often develop silently between routine rounds." Masimo president Tim Benner said the company intends to keep expanding smartSET to other clinical needs. Those quotations are theirs, as Masimo prints them. The product is sold to hospitals and health systems, through evaluations with Masimo representatives, not to consumers.

The picture is a Masimo press image of a smartSET pulse-oximetry sensor wrapped around a patient's finger on a hospital bed, with a smartSET adhesive sensor shown in the lower left. It is from Masimo's clearance release. The frame does not print a calendar date.

In plain terms, Masimo said on Saturday that the FDA cleared an AFib-flagging feature on its Radius VSM wearable, as part of a pulse-oximetry platform it calls smartSET, alongside an already-cleared alert for opioid-related breathing problems. The AFib tool looks at the pulse wave and flags rhythms that look like AFib so a clinician can order an ECG. Masimo's own unpublished data says 97% sensitivity and 100% specificity. It is a hospital product, not a consumer gadget.