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美国食品药品监督管理局批准新款Apple Watch的睡眠呼吸暂停功能

FDA clears sleep apnoea feature for new Apple Watch

pharmaphorum 等信源发布 2024-09-17 17:53

可切换为仅中文


Apple has the FDA authorisation it needs to bring its software for detecting sleep apnoea to the Apple Watch, coinciding with the launch of its new operating system for the wearable.The Breathing Disturbances function is part of watchOS 11, which makes its debut today alongside the release of the latest Apple Watch Series 10 which was revealed at the company's new product reveal earlier this month and is due to become available on 20th September.The FDA cleared the app towards the end of last week via its 510(k) de novo premarket notification pathway, describing it as an over-the-counter device that can provide a notification of the risk of sleep apnoea to people who have previously not been diagnosed with the disorder.The development comes shortly after Apple also claimed a green light from the FDA to use its AirPods earbuds as OTC hearing aids using its Hearing Aid Feature (HAF) app, the first time that a consumer device has been cleared for that purpose.Apple confirmed today that the sleep apnoea notification feature will be rolled out to Apple Watch Series 9, Series 10, and Ultra 2 devices.It uses the accelerometer in the watches to monitor small movements at the wrist during sleep that are associated with interruptions in normal respiratory patterns and according to Apple uses an algorithm trained on thousands of nights of clinical-grade sleep apnoea tests to interpret the results.'Users can view their nightly Breathing Disturbances in the Health app, where they are classified as elevated or not elevated, and can be viewed over a one-month, six-month, or one-year period,' said the tech giant.Sleep apnoea is most common in people who are overweight and affects approximately a billion people worldwide.

苹果公司获得了美国食品和药物管理局(FDA)的授权,需要将其用于检测睡眠呼吸暂停的软件带到苹果手表(Apple Watch)上,与此同时,苹果公司推出了针对可穿戴设备的新操作系统。呼吸干扰功能是watchOS 11的一部分,随着最新的Apple Watch系列10的发布,watchOS 11将于今天首次亮相。最新的Apple Watch系列10将于本月初在该公司的新产品发布会上发布,并将于9月20日上市。。此前不久,苹果公司还宣布美国食品和药物管理局(FDA)允许其AirPods耳塞使用其助听功能(HAF)应用程序作为非处方助听器,这是消费者设备首次被清除用于此目的。苹果公司今天证实,睡眠呼吸暂停通知功能将在Apple Watch Series 9、Series 10和Ultra 2设备上推出。它使用手表中的加速计来监测与正常呼吸模式中断相关的睡眠期间手腕的微小运动,据苹果称,它使用了一种经过数千夜临床级睡眠呼吸暂停测试训练的算法来解释结果这位科技巨头说,用户可以在健康应用程序中查看他们的夜间呼吸障碍,这些呼吸障碍分为升高或不升高,可以在一个月、六个月或一年的时间内查看。睡眠呼吸暂停最常见于超重人群,影响全球约10亿人。

It results in repeated interruptions in breathing during sleep ca.

它会导致睡眠期间反复中断呼吸。