FDA-Cleared.
FDA-Designated Breakthrough Device.
FDA-cleared and recognized by the FDA with its prestigious Breakthrough Device designation, GyroStim represents a new generation of precision neurotechnology distinguished by rigorous regulatory review, clinical innovation, and the potential to transform the treatment of conditions associated with vestibular dysfunction.
These landmark FDA achievements establish GyroStim as one of the pioneering breakthrough medical technologies shaping the future of precision neurorehabilitation.
Indication for use statement
GyroStim is intended to assist in the treatment of balance disorders and vestibular dysfunction in adult patients, age 18 and older, up to 400lbs. It is intended to be used by a trained medical professional as prescribed by physician in a clinical environment.
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FDA-cleared: K220231
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FDA-designated as a Breakthrough Medical Device
Breakthrough Device Designation
August 10, 2021
In a landmark decision, the FDA awarded GyroStim its prestigious Breakthrough Device designation after determining that the technology demonstrated "a reasonable expectation for providing more effective treatment relative to the current standard of care for balance disorders and vestibular dysfunction."
Reserved for a select group of transformative medical technologies, this distinction set GyroStim apart from every other device in its category. Today, GyroStim remains the first and only medical device for vestibular dysfunction to receive the FDA's Breakthrough Device designation—recognizing its outstanding potential to redefine patient care and advance the future of neurorehabilitation.
FDA Clearance K220231
April 22, 2022
UltraThera achieved a defining milestone when the FDA granted clearance to market GyroStim for the treatment of balance disorders and vestibular dysfunction. This pivotal authorization marked the beginning of a new era in neurotherapeutics and signaled the emergence of a new paradigm in technology-assisted multimodal neurorehabilitation.
Vestibular dysfunction encompasses a broad range of conditions that disrupt the brain's ability to process sensory information essential for balance, spatial orientation, and movement. Because the vestibular system influences far more than balance alone, this clearance established the foundation for GyroStim's application across a broad spectrum of neurological conditions known to benefit from vestibular rehabilitation therapy.
