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What exactly does “breakthrough” mean?
The word breakthrough carries a kind of weight: It’s a dramatic step forward, a critical advance in science or technology. But in the context of the Food and Drug Administration’s breakthrough devices program, the definition is far fuzzier. Earlier this week, Katie and Mario published an investigation into the FDA’s fast-track program for medical devices and how it’s been a boon to industry with unclear benefits to patients. In a new follow-up story, they delve into the elusive questions of how the agency admits products to the program, what evidence is required, and how companies navigate the application process.
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