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

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 function and a photoplethysmograph analysis software to detect irregular heart rhythm