FDA Breakthrough Device Designation
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.