The atrial fibrillation (AFib) detection feature on Apple Watch devices has become the first digital health technology to be qualified under a programme recently introduced by the FDA designed to encourage the development of medtech.

Apple Watch设备上的心房颤动（AFib）检测功能已成为FDA最近推出的一项旨在鼓励medtech发展的计划下第一项获得资格的数字健康技术。

The US regulator published guidance on the Medical Device Development Tools (MDDT) framework last year, a voluntary process that aims to reduce the regulatory burden of evaluating new technologies and speed up the review process.

美国监管机构去年发布了《医疗器械开发工具（MDDT）框架指南》，这是一个自愿过程，旨在减轻评估新技术的监管负担并加快审查过程。

The approach covers a range of products, including biomarker tests, clinical outcome assessments, and non-clinical tests, and provides an endorsement that the data supports their safety, effectiveness, or performance.

该方法涵盖了一系列产品，包括生物标志物测试，临床结果评估和非临床测试，并提供了数据支持其安全性，有效性或性能的认可。

The FDA notes that the Apple Atrial Fibrillation History Feature – which provides a non-invasive way to check estimates of AFib burden – has now been qualified as a biomarker test that can be used as a secondary effectiveness endpoint in clinical studies.

FDA注意到，苹果房颤病史功能-提供了一种非侵入性的方法来检查AFib负担的估计值-现已被鉴定为生物标志物测试，可作为临床研究的次要有效性终点。

AFib is a type of irregular heart rhythm (arrhythmia irregular heart rhythms) where the upper chambers of the heart beat out of sync with the lower chambers, and affects around 2% of people under the age of 65 and 9% of those older, according to Centres for Disease Control and Prevention (CDC) data..

根据疾病控制与预防中心（CDC）的数据，AFib是一种不规则心律（心律失常-不规则心律），其中上腔与下腔跳动不同步，影响约2%的65岁以下人群和9%的老年人。。

Apple’s software uses artificial intelligence to regularly check heart rhythms for signs of AFib and – after a week of measurements – provides an estimate of how often a patient’s health was beating irregularly while wearing an Apple Watch.

苹果公司的软件使用人工智能定期检查心律是否有AFib的迹象，经过一周的测量后，可以估计出患者佩戴苹果手表时身体不规则跳动的频率。

Specifically, the MDDT qualification covers its use within studies intended to evaluate the safety and effectiveness of cardiac ablation devices used to treat AFib, but in principle could also apply to other studies where there is a need to provide an estimate of how long people have AFib over time.

具体而言，MDDT资格涵盖了其在旨在评估用于治疗AFib的心脏消融装置的安全性和有效性的研究中的使用，但原则上也可以应用于其他需要提供人们随着时间推移患有AFib的时间估计的研究。

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In a 400,000-subject study of the Apple Watch’s ability to detect irregular heart rhythms that may signal AFib, published in 2019, it was found that 34% of individuals who received a notification of arrhythmia were later found to have AFib using an ECG, with a positive predictive value for the AI of 84%..

在2019年发表的一项关于苹果手表检测可能发出AFib信号的不规则心律的能力的40万主题研究中，发现34%收到心律失常通知的个体后来使用心电图发现患有AFib，AI的阳性预测值为84%。。

Apple has also reported anecdotal incidences of Apple Watch users receiving a warning of arrhythmia that has prompted them to seek medical advice, potentially saving their lives. The detection feature – not the history feature covered by the MDDT qualification – was approved by the FDA in 2022.

苹果还报道了苹果手表用户收到心律失常警告的轶事，这促使他们寻求医疗建议，可能挽救了他们的生命。检测功能-而不是MDDT资格所涵盖的历史功能-于2022年获得FDA批准。

Photo by David Švihovec on Unsplash

照片由DavidŠvihovec在Unsplash上拍摄