STAT April 19, 2022
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.
“People are trying to say, ‘Well, breakthrough must mean it’s really great, and so we should pay for it, regardless of whatever evidence there is,’ and...
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