[hollerith]

Apple is adding features that compete with medical devices, but my guess is that they haven't developed any devices that require FDA approval because the approval process would eat up too much mental bandwidth among their executives. Apple seems to have a healthy instinct for conserving executive bandwidth.

[dymk]

AirPods Pro are FDA approved as hearing aids

Apple Watch has FDA marketing authorization for afib detection (and looks like sleep apnea detection as well)