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FDA: Apple De Novo Approvals Signal Innovation To Digital Health Firms

The latest Apple Watch includes an electrocardiogram that has received de novo clearance from US FDA to detect irregular heart rhythms. The approval, say two top US FDA regulators, is a signal to the digital health industry that the agency is trying to help them innovate.

Medical app

Apple Inc.'s closely watched moves into the health-care sector in recent years has finally resulted in an US FDA-approved product. The tech giant announced Sept. 12 it gained de novo classifications for an electrocardiogram functions and software that will be embedded in the latest Apple Watch.

After several years of skepticism, big tech companies such as Apple, Google and others have been making inroads in recent years with FDA and this approval may be a big...

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