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breakthrough device program

Coverage of breakthrough device program in the Nexus archive.

Earliest in view: Jun 24 · 08:30 UTCMost recent: Jun 24 · 08:30 UTC

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HEALTHJun 24 · 08:30 UTCSTAT NEWS
STAT+: What an abandoned heart failure trial says about ‘breakthrough’ devices that don’t reach patients
LivaNova's VITARIA vagus nerve stimulator for heart failure, designated a FDA breakthrough device, failed to meet trial success criteria after enrolling 500 patients. The FDA's breakthrough device program, aimed at accelerating innovative treatments, did not ensure the device's market success.