Masimo has obtained US Food and Drug Administration (FDA) 510(k) clearance for prescription (Rx) and over-the-counter (OTC) use of its Masimo W1 medical watch.
Masimo W1 is claimed to be the first FDA-approved watch to offer pulse rate (PR) and continuous real-time oxygen saturation (SpO₂) for OTC and Rx use.
It now has clearance for broader use in the US as a medical device for adults in clinics, hospitals, long-term care facilities and at home.
This watch derives its clinical power from the integrated Masimo MW-1 sensor, hardware and software module. It incorporates more than 30 years of expertise in Signal Extraction Technology pulse oximetry into a single wearable module.
Masimo W1 features an integrated optical sensor and electrocardiogram (ECG) electrode pads, which can be used for detecting physiological signals.
Leveraging the company’s signal processing algorithms, the Masimo MW-1 module processes these signals to output high-resolution SpO₂, PR, heart rate and perfusion index from an ECG.
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Under the care of a physician, continuous pulse oximetry data can offer a clear picture of changes in oxygen saturation to help patients better manage their oxygen levels daily.
The continuous data from the module is shown in real-time on the touchscreen of the watch in an easy-to-interpret format.
Furthermore, the SpO₂ and PR values are displayed in red when they fall outside their normal ranges. This helps individuals detect low PR, high PR and low oxygen saturation.
Masimo founder and CEO Joe Kiani said: “We are excited about the hospital-to-home innovations the Masimo W1 can bring to the US, with this FDA clearance and the empowerment of patients at home.”
The Masimo W1 and the integrated Masimo MW-1 module can also be used for the spot-checking of functional oxygen saturation of arterial haemoglobin and PR.