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FDA's Speedy Apple Watch De Novos Raise Questions For Industry

Executive Summary

The recent US FDA de novo approvals for heart-rhythm analysis software on Apple's latest Apple Watch, which took about 30 days from submission to a decision that aligned with Apple's high-profile launch event, raised eyebrows in the medtech industry. Some in industry are concerned that the tech giant received preferential treatment over smaller companies, setting a bad precedent. But some say it could be a positive sign for the digital health industry at large.

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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.

Scott Gottlieb Calls It Quits After An Active Tenure At US FDA

The commissioner says he will step down next month, leaving a legacy of active policy development, but also a lot of initiatives and pilot projects that are in the middle of being implemented.

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Scott Gottlieb's FDA continues to push out policy reforms and experiments at a rapid pace, with special focus on digital and AI technologies. In parallel, US Medicare officials are more publicly signaling plans to roll out policies for a quicker path to reimbursement for new devices. However, public scrutiny of whether device regulations properly protect patient safety is growing, and it could have an impact. 

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