ShiraTronics, Inc. a privately held medical device company, announced today that it has been granted a Breakthrough Device designation by the Center of Devices and Radiological Health (CDRH) of the FDA for its innovative neurostimulation therapy targeting the millions of chronic migraine sufferers.
The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
“We are thrilled to have received this important designation from the FDA. This reinforces the severity of the disability these patients suffer and the importance of new therapy options,” said Lynn Elliott, Chief Executive Officer of ShiraTronics, Inc.
“We applaud FDA’s Breakthrough Device designation on behalf of the millions of patients suffering from chronic migraine who are actively seeking treatment options to deal with this life limiting and severely disabling condition,” said Mudit K. Jain, PhD, a co-founder and Chairman of the Board of ShiraTronics, Inc.