The US Food and Drug Administration (FDA) has proposed a new innovation pathway to serve as a priority review programme to speed up the adoption of breakthrough medical devices. The programme is designed to encourage cutting-edge technologies among medical device manufacturers by strengthening the nation’s research infrastructure for developing breakthrough technologies and advancing regulatory science. The proposed actions of the programme include establishing third-party certification program for US medical device test centres to promote new technologies, creating publicly available curriculum for medical device development, and using data collected outside the US. As part of the initiative, the FDA has also accepted the first submission, a brain-controlled, upper-extremity prosthetic from the Defense Advanced Research Projects Agency (DARPA), which will serve as a pilot for the programme. Because of the transformative nature of the devices in the innovation pathway, the FDA could conduct premarket reviews within 150 days, nearly half the time it currently takes to review most premarket approval applications. The FDA will seek further public comment before the pathway is used more broadly.