Breakthrough Medical Device

On August 10th, 2021, the FDA completed an extensive review process and designated GyroStim as a Breakthrough Medical Device, stating GyroStim has: “a reasonable expectation for providing more effective treatment relative to the current standard of care for balance disorders and vestibular dysfunction.” 
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The Breakthrough Device designation is a monumental accomplishment and a significant distinction that sets GyroStim apart from all other devices in its category: GyroStim is the first and only device for the treatment of balance disorders and vestibular dysfunction the FDA has designated as a Breakthrough Medical Device.