Fierce Biotech November 22, 2023
About a year after beginning its full market launch, Masimo’s W1 smartwatch can now be used as a medical device in the U.S.
The wearable device has earned FDA clearance for its medical applications, Masimo announced this week. The regulatory nod allows the smartwatch to be used as a remote patient monitoring device, constantly tracking oxygen saturation levels and pulse rates for wearers whether they’re in hospitals, long-term care facilities or their own homes.
Those round-the-clock data points are especially important when it comes to monitoring the health of people who are recovering from surgery or have been diagnosed with a condition like chronic obstructive pulmonary disease or congenital heart failure.
The W1 wearable is powered by Masimo’s signature Signal...
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