The GyroStim is FDA-cleared to assist in the treatment of balance disorders and vestibular dysfunction in adult patients, age 18 and older, up to 400lb. It is intended to be used by a trained medical professional as prescribed by a licensed medical provider, in a clinical environment.
August 10, 2021
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.
April 27, 2022
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.
Now, with FDA marketing authorization, and with FDA designation as a Breakthrough Medical Device, it is official:
GyroStim is an FDA-Cleared Breakthrough Medical Device.
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.