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FDA / Regulatory Status

GyroStim is designated by the FDA as a Breakthrough Medical Device. It integrates well with existing treatment modalities, provides access to treatment for lower functioning patients, and can provide a significant enhancement to clinical outcomes.

August 10, 2021

GyroStim Designated as
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.” 

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.

 

FDA Statistics

 

As of March 31, 2022, in total, there are 657 devices that have been granted Breakthrough Device designation since the program began in 2015.

The following FDA-published metrics reveal just how unique and significant it is that GyroStim succeeded with both Breakthrough Device Designation AND 510(k) marketing authorization:

  • The FDA has granted marketing authorization to approximately 40,000 medical devices.

  • Of the 40,000 devices, 657 have been granted Breakthrough Device Designation.

  • Of the 657 devices, only 44 have successfully obtained FDA clearance for marketing as a Breakthrough Medical Device.

  • Of the 44 devices, only 11 are 510(k) approved- GyroStim is 12th in the history of the FDA.

  • Of the 40,000 devices, GyroStim is the only device in its clinical panel to be granted Breakthrough Device Designation AND to have succeeded in obtaining FDA clearance for medical device marketing. 


GyroStim is the 46th medical device in the history of the FDA to have been granted both Breakthrough Medical Device designation and FDA marketing authorization.

​April 27, 2022

GyroStim Receives

FDA-Clearance

On April 27, 2022, the FDA granted authorization for UltraThera to market the GyroStim as an FDA-cleared medical device for use in the treatment of balance disorders and vestibular dysfunction.

This accomplishment is the culmination of tremendous dedication and effort at UltraThera, and marks the beginning of a new era for GyroStim.

FDA Breakthrough
Device Program

 

The FDA Breakthrough Device designation program is a rigorous and lengthy process. To receive this prestigious designation, an FDA panel will evaluate documentation to determine if a device meets specific criteria. UltraThera successfully demonstrated to the FDA that treatment outcomes with the GyroStim meet Criterion 1 and at least one of the sub-paragraphs listed in Criterion 2 of the FDA requirements:

“Criterion (1) devices that:

  • provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; and


Criterion (2) devices that:

  • (A) represent breakthrough technologies;

  • (B) for which no approved or cleared alternatives exist;

  • (C) that offer significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or

  • (D) the availability of which is in the best interest of patients.

The Breakthrough Device designation is a monumental accomplishment and a significant distinction that sets GyroStim apart from all other devices in this clinical panel.

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.

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