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.

The two-year results from the PARTNER 3 trial showed transcatheter aortic valve replacement with Edwards Lifesciences' Sapien 3 system was statistically non-inferior to surgical valve replacement in low-risk patients. The one-year results from the trial had shown TAVR was superior to surgery in low-risk patients.

In this edition of the Device Week podcast, Medtech Insight managing editor Marion Webb discusses LifeSignals’ plans for a vital-sign monitoring patch that could help remotely monitor patients during the pandemic. Deputy editor Reed Miller highlights some important device trials presented at the American College of Cardiology online conference.