9 月 19 日，美国食品和药物管理局 (FDA) 批准了 Apple Watch Series 9、10 和 Watch Ultra 2 的睡眠呼吸暂停检测功能。这项新功能是在最近的 iPhone 16 发布会上宣布的，并将通过 即将推出的 watchOS 11 更新。 要使用此功能，您的手表必须跟踪一个月内 10 个不同的睡眠时段。 在此期间之后，手表通过使用内置加速度计分析夜间干扰来识别与睡眠呼吸暂停相关的任何潜在问题。 尽管它不能提供明确的诊断，但 FDA 认为该功能是一种非处方设备，旨在检测睡眠呼吸暂停的可能风险。 如果发现，您应该咨询医疗专业人士进行进一步评估。 睡眠呼吸暂停会扰乱睡眠期间的正常呼吸模式，导致各种健康问题，如失眠、头痛、白天过度嗜睡以及心脏病和中风等长期并发症。 虽然多家科技公司已经提供睡眠呼吸暂停监测技术，但 Withings 和三星此前已获得 FDA 批准。 然而，由于专利纠纷，苹果不得不禁用在美国销售的手表上的血氧水平测量功能。
On September 19th, the US Food and Drug Administration (FDA) approved sleep apnea detection functionality for the Apple Watch Series 9, 10, and Watch Ultra 2. This new capability was announced at the recent iPhone 16 launch event and will be available via the upcoming watchOS 11 update. To use this function, your watch must track 10 separate periods of sleep across a month. After this period, the watch identifies any potential issues related to sleep apnea by analyzing nightly disruptions using the built-in accelerometer. Although it does not provide a definitive diagnosis, the FDA considers this feature a non-prescription device designed to detect possible risks of sleep apnea. If detected, you should consult a medical professional for further evaluation. Sleep apnea interrupts normal breathing patterns during sleep, leading to various health problems like insomnia, headaches, excessive daytime sleepiness, and long-term complications such as heart disease and stroke. While several tech companies already offer sleep apnea monitoring technology, Withings and Samsung were previously granted FDA approval. However, due to a patent disagreement, Apple had to disable the blood oxygen level measurement feature on their watches sold within the United States.
The U.S. Food and Drug Administration Monday published approval for sleep apnea detection on the Apple Watch Series 9, Series 10, and Watch Ultra 2. The green light comes four days ahead of the Series 10’s September 20 release date.
The feature, announced at last week’s iPhone 16 event, will arrive as part of the imminent watchOS 11 release. Once enabled, it requires 10 nights of sleep tracking data spread out over a 30-day span to determine whether a user may have the condition. During that time, it also offers insights into nightly sleeping disturbances, utilizing the on-board accelerometer.
The FDA classes the feature as an “over-the-counter device to assess risk of sleep apnea.” Apple is quick to note that the addition is not a diagnostic tool. Rather, it will prompt users to seek a formal diagnosis from a healthcare provider. The condition, which causes breathing to become shallower or repeatedly stop during the night, is associated with a variety of different symptoms. The Mayo Clinic notes that it can cause insomnia, headaches, daytime sleepiness, and other longer-term conditions.
Apple isn’t the first consumer electronics firm to offer the feature. Withings has offered sleep apnea detection in devices for some time, while Samsung received FDA approval for its Galaxy Watch line earlier this.
The feature arrives as another — blood oxygen detection — has been disabled on Apple Watches in the U.S. over an ongoing patent dispute.