As FDA offers breakthrough designation to device makers, patients and providers are left with questions

What happens after the FDA designates a new device a breakthrough? The process has remained largely out of sight for the very patients the devices are supposed to help.

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.

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