On Aug. 12, 2024, Masimo announced that its Masimo W1 medical watch received FDA 510(k) clearance for connectivity, allowing it to be integrated with the company’s telemonitoring solution.
About the Masimo W1 watch
The Masimo W1 is a medical watch that detects physiological signals and tracks parameters such as oxygen saturation (SpO2), pulse rate (PR) and heart rate. With real-time pulse oximetry, it allows patients to track measurements to help manage recovery, chronic conditions or overall wellness. The device uses a single-channel electrocardiogram and a pulse oximeter sensor.
The latest FDA clearance allows the Masimo W1 watch to connect to the Masimo SafetyNet telemonitoring system. Using secure Bluetooth connectivity, wrist-based measurements from the watch are relayed to caregivers through a smartphone app. This allows remote caregivers to receive notifications about patient data.
According to the company’s press release, the addition of the FDA-cleared Bluetooth connectivity allows patients to use their phone to input additional symptoms in the app, view data and trends, conduct virtual visits and view educational resources.
In 2023, the Masimo W1 received FDA clearance as the first medical watch to provide continuous SpO2 and PR for over-the-counter and prescription use at home and in hospitals.
The Masimo W1 medical watch is indicated for adults in hospitals, clinics, long-term care facilities and homes.
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