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The FDA's green-lighting of the sleep apnea feature comes on the heels of the agency's approval of Apple's AirPods Pro 2 as over-the-counter hearing aids for users with mild to moderate hearing ...
The Food and Drug Administration (FDA) has approved Apple’s new sleep apnea detection feature on three of its latest watch models, the company confirmed Monday. The feature — available for the ...
The Apple Watch Series 10 also includes a sleep apnea detector, pending FDA approval, which is also planned to be supported by the Apple Watch Series 9 and the Apple Watch Ultra 2. To enhance phone call quality, the Series 10 incorporates a neural network that suppresses background noise for clearer conversations.
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
Apple has received approval to change the way its smartwatches function so the company can overcome the Apple Watch ban imposed by a US court. The fix would eliminate a feature Apple has marketed ...
Designed to compete with the Apple Watch Series 3, it is the successor to both the Blaze and the Surge. Like the Surge, the Ionic uses built-in GPS, using GLONASS to tap into global satellites and provide better accuracy when recording exercises, with the antenna being integrated into the watch case for a stronger connection. The Ionic also ...