They have world wide approvals for their medical grade XCEL devices they sell to Pharma. I don't believe they have finished product development for any of their new consumer grade medical devices, so no approvals until they are completed.
The new features on the watch will probably not require regulatory approval, just like Apple and Samsung don't have approval for their soft 'medical' parameters eg SpO2.
Happy to be corrected if I have missed any recent approvals.
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