Hardware Podcasts

#333: Exploring Breakthrough Device Designation

Global Medical Device Podcast · 25 Aug 2023 · 35m · Episode 333

What this episode covers

Etienne Nichols hosts Ellie Reynolds, Associate Director at Proxima Clinical Research, to discuss the FDA's Breakthrough Device Designation program. They cover the eligibility criteria, such as treating life-threatening conditions, and the benefits like priority review and Sprint Discussions. Reynolds clarifies that CMS reimbursement is no longer automatic and explains how to navigate competitive landscapes where rivals also hold the designation.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
FDA, CMS, Proxima Clinical Research, Greenlight Guru
Also
510(k), De Novo, PMA

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