Fierce Biotech February 12, 2024
Andrea Park

Amid rumors that Apple is in the process of adding a sleep apnea detection feature to its namesake wearables, Samsung has beat it to the punch.

The Korean electronics giant announced over the weekend that the FDA had handed down a de novo clearance for its own smartwatch-based sleep apnea feature, which it said marked the regulator’s first such authorization.

The feature was cleared in Korea last fall and was slated to begin its rollout in the country early this year; with FDA clearance now in hand, too, Samsung said Galaxy Watch users in the U.S. will be able to access the tool starting in the third quarter of this year.

The sleep apnea detection feature is housed alongside Samsung’s...

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Topics: Digital Health, FDA, Govt Agencies, Technology, Wearables
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