STAT April 18, 2022
Since launching in 2017, an ambitious and secretive Food and Drug Administration program to speed up medical device development has helped at least 44 authorized devices hit the market.
There are now more than 650 devices that have earned “breakthrough designation,” a signal that the agency believes — based on early data and the options currently available to patients — that a product could one day be “more effective” at treating or catching serious or even fatal conditions. STAT has identified details on more than two-thirds of those products in an authoritative new database, the Breakthrough Device Tracker.
The database sheds light on what happens after the FDA designates a new device a “breakthrough,” a process that has remained largely...
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