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Investigating an FDA program for medtech innovation


In a constantly-growing pool of innovative medical technologies, what does it take to be a “breakthrough”? For the last five years, the FDA’s Center for Devices and Radiological Health has applied its own definition as part of a secretive program to accelerate development and review of devices with the potential to improve care for the sickest patients. But a STAT investigation has shown that while the Breakthrough Device Program has driven significant gains for companies, its ability to drive meaningful improvements for patients is far from clear.

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