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FDA Explains Why It Approved Apple Watch's De Novo Despite Missing Primary Endpoint

De novo summary documents published by the US FDA sheds more light on the agency’s work approving two de novos for Apple Watches last year. At the time, the approvals sparked concern from industry stakeholders on whether the company received preferential treatment. Former FDA Commissioner Scott Gottlieb pushed back against the notion in a lengthy blog post late last year.

Apple Watch
FDA has shed more light on its de novo approvals of cardiac apps on the Apple Watch

When the US FDA approved a de novo application for an irregular rhythm notification feature for Apple Watch Series 4 in record time, it did so despite the application not meeting its primary endpoint. The agency says that while it missed the mark on the first endpoint, regulators approved the de novo based on the secondary endpoint and other analyses.

Apple Inc.’s latest watch sparked some controversy last year when it received two de novos for an electrocardiogram...

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