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Behind The Breakthroughs: FDA Releases Expedited Program Data For First Time

 
• By Elizabeth Orr

New data from the US FDA shows that neurology and cardiovascular devices are the most likely to be accepted to – and cleared for market via – the breakthrough devices pathway.

Red arrow breaking through concrete wall to hit bullseye.
• Source: Shutterstock

For the more than five years of its existence, the US Food and Drug Administration’s breakthrough devices pathway has operated under a veil. While the agency has announced some breakthrough device approvals, and other breakthrough designations have been announced by the companies themselves, there’s been no single comprehensive source to show what devices are making the cut.

[Click here for Medtech Insight’s exclusive breakthrough devices tracker.]

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More from Policy & Regulation

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
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• By Brian Bossetta

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