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.
美国食品药品监督管理局周一批准了 Apple Watch Series 9、Series 10和 Watch Ultra 2 的睡眠呼吸暂停检测。这一批准在 Series 10 的 9 月 20 日发布日期前四天公布。
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.
该功能，在上周的 iPhone 16 发布会上宣布，将作为即将发布的 watchOS 11 的一部分推出。一旦启用，它需要在 30 天内收集 10 晚的睡眠跟踪数据，以确定用户是否可能患有该疾病。在此期间，它还利用内置加速度计提供夜间睡眠干扰的洞察。
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.
FDA 将该功能归类为“评估睡眠呼吸暂停风险的非处方设备”。苹果公司迅速指出，这一新增功能并不是诊断工具。相反，它会提示用户寻求医疗提供者的正式诊断。该病症会导致夜间呼吸变浅或反复停止，伴随多种不同的症状。梅奥诊所指出，它可能导致失眠、头痛、白天嗜睡以及其他长期健康问题。
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.
苹果并不是第一家提供该功能的消费电子公司。Withings 的设备已经提供睡眠呼吸暂停检测一段时间，而三星的 Galaxy Watch 系列在早些时候获得了FDA 批准。
The feature arrives as another — blood oxygen detection — has been disabled on Apple Watches in the U.S. over an ongoing patent dispute.
该功能的到来正值另一个功能——血氧检测——因正在进行的专利争议而在美国的 Apple Watch 上被禁用。由于持续的专利争议。
Comment 评论