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FDA-Cleared
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FDA Breakthrough Device Designated
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.
BREAKTHROUGH DESIGNATION IS ONLY THE BEGINNING.
FDA Breakthrough Devices must still meet the FDA’s rigorous standards for safety and effectiveness to receive marketing authorization. GyroStim achieved both.
FDA Clearance K220231
April 22, 2022
UltraThera achieved a defining milestone when, just eight months after GyroStim was accepted into the FDA Breakthrough Devices Program, the FDA cleared GyroStim for the treatment of balance disorders and vestibular dysfunction. Breakthrough Device designation alone does not authorize a device for market. Designated devices must still successfully satisfy the FDA’s rigorous requirements for marketing authorization, a distinction achieved by only a fraction of the devices that have entered the Breakthrough Devices Program. GyroStim successfully crossed that critical regulatory threshold, earning FDA clearance while retaining its Breakthrough Device designation.
This pivotal authorization established GyroStim as an FDA-cleared medical device and marked a major advancement in the evolution of precision, technology-enabled multimodal neurorehabilitation.
Vestibular dysfunction encompasses a broad range of conditions that disrupt the brain’s ability to process and integrate sensory information essential for balance, spatial orientation, and movement. But the vestibular system extends far beyond balance alone. Through its extensive connections throughout the brain, vestibular function is closely integrated with vision, proprioception, sensorimotor control, spatial awareness, navigation, attention, memory, and other cognitive processes. This extraordinary neurological reach helps explain why vestibular rehabilitation can have relevance across a diverse range of neurological and functional impairments and provides an important scientific foundation for the broader clinical potential of GyroStim.
