Skip to Main Content

The Breakthrough Device Program is approaching terminal velocity. The Food and Drug Administration, looking to accelerate access to innovative devices, has now labeled nearly 700 products as breakthroughs while they’re under development. But until recently, relatively few have reached the market.

A STAT analysis shows that FDA authorizations of breakthrough devices have picked up significantly this year. The agency has already authorized 11 breakthrough devices in the first half of this year, compared to 15 in all of 2021 and 11 the year prior. There are now 54 breakthrough devices that have earned authorization. But as that list grows — and as companies continue to reap the financial benefits of the label —  it’s still unclear whether they truly improve outcomes.


“What is the overall evidence that the breakthrough devices that are coming to market through the program are improving clinical outcomes?” asked Sanket Dhruva, a cardiologist and health policy researcher at the University of California, San Francisco. “That still remains an open question. And it remains more of an open question because we’re seeing more breakthrough device designations, and now we’re seeing that percolate down to the devices coming to market.”

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!


Create a display name to comment

This name will appear with your comment

There was an error saving your display name. Please check and try again.