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Fitbit's Pivot To Healthcare Bolstered By Approvals For ECG Wearable Device

机译：Fitbit对医疗保健的枢轴被ECG可穿戴设备的批准支持

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1.Fitbit continues its shift towards healthcare with US and EU regulatory clearance for its electrocardiogram monitoring app to flag early signs of atrial fibrillation. 2.Uptake will be driven by unmet needs in detecting the condition and supported in the long term by growing demand for remote monitoring devices. 3.Approvals bring Fitbit up to speed with competing wearable manufacturers. 4.Transaction with Google will support Fitbit's ongoing pivot to healthcare. Fitbit continues its pivot towards healthcare with significant regulatory wins. On September 14 2020, Fitbit gained US FDA clearance and EU CE mark approval for its new electrocardiogram (ECG) app to track heart rhythm and flag early signs of atrial fibrillation. The approvals were supported by a small multi-site study carried out in the US to determine the algorithm's accuracy in detecting atrial fibrillation. Results showed that the algorithm was able to identify patients with a normal heart rate 100% of the time and patients with atrial fibrillation 98.7% of the time.
机译：1.与美国和欧盟监管清关继续转向医疗保健的转变，为其心电图监测应用程序以旗上心房颤动的早期迹象。 2.通过未满足在长期检测条件并通过对远程监控设备的需求增长的情况来支持的情况下，将通过未满足的需求驱动。 3. 33.普通符合竞争佩戴厂商带来Fitbit。 4.与Google相关联将支持Fitbit的持续枢轴到医疗保健。 Fitbit继续将其枢转朝着医疗保健，具有重要的监管胜利。 2020年9月14日，Fitbit获得了美国FDA清除和欧盟CE标志，为其新的心电图（ECG）应用程序批准，以跟踪心律的心律和心房颤动的早期迹象。批准由美国进行的小型多网站进行支持，以确定算法在检测心房颤动方面的准确性。结果表明，该算法能够识别患有正常心率的患者100％的时间和心房颤动的患者98.7％的时间。

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