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Post# of 175479
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Alias Born 07/15/2012

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Tuesday, 12/26/2023 1:14:39 PM

Tuesday, December 26, 2023 1:14:39 PM

Post# of 175479
BDD granted,,,,,The Breakthrough Device classification will enhance the schedule priority for our upcoming IDE submission seeking authorization to begin human clinical trials.

The FDA’s Breakthrough Devices program facilitates accelerated development and expedites the review of breakthrough technologies to help patients potentially gain timely access to technologies that can provide more effective treatment options.
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