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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.

The agency doesn’t release the names of breakthrough-designated devices before they’ve reached the market, nor does it spell out why products earn the status. But STAT has gleaned new insights into how the agency determines what makes the cut as part of an investigation built on hundreds of public documents and interviews with dozens of companies, regulatory experts, and researchers.


Earning breakthrough status — which typically comes early in the regulatory process, before a submission for marketing authorization — has become a business imperative for medical device companies. Once they get the label, it allows them to talk more often with regulators before seeking authorization to sell their products. It’s the agency’s way of saying those devices, if the data bear out, could provide “more effective” treatment or diagnosis for deadly and debilitating conditions.

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