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GyroStim is designated by the FDA as a breakthrough medical device.

​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.

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.

 

Standards of Conformity

GyroStim has undergone rigorous third-party safety testing at Intertek Testing Laboratories, Inc. for regulatory compliance and FDA clearance.

The table below provides information on GyroStim’s conformance with regulatory and FDA consensus standards related to design, development, and manufacturing of the GyroStim medical device.

Standard # & Edition
Standard Title
FDA Requirement
AAMI HE 75:2009
Human Factors Engineering – Design of Medical Devices, Section 9 – Usability Testing
5-57
ISO 10993-1 Fifth Edition 2018-08
Human Factors Engineering – Design of Medical Devices, Section 9 – Usability Testing
2-256
ISO 10993-5:2009/(R)2014
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
2-245
ISO 10993-10 Third Edition 2010-08-01
Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
2-174
IEC 63266-1:2015
Medical Devices – Part 1: Application of usability engineering to medical devices
-
IEC 60601-1-6 Edition 3.1 2013-10
Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Usability
5-89
ANSI/AAMI/IEC 60601-1-2:2014
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
19-8
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
19-4
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