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Wednesday, March 27, 2024 10:28:58 PM
Masimo reels in FDA nod for pulse oximetry smartwatch amid Apple Watch patent spats
The split is slated to place a number of FDA-cleared medical devices squarely within a consumer-focused tech company built off of Masimo’s long history with sensors and patient data platforms.
Its Stork infant monitor—with its wearable, vital sign-tracking baby boot, digital camera and alerting app—received the agency’s green light last December. The device measures blood oxygen levels, pulse rate and skin temperature and can notify caregivers when the child turns over and begins sleeping facedown.
Last year also saw Masimo claim an FDA nod for its W1 smartwatch, with the agency clearing it for monitoring patients remotely whether they’re in hospitals, long-term care facilities or their homes.
The pulse-ox-equipped watch made its debut in the middle of a so-far-successful patent battle with Apple and its Apple Watch, which saw sensor-laden models fall subject to an import ban earlier this year. Apple began selling pulse-ox-free versions of its wearable in January.
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