25th January 2019- Helius Medical Technologies, Inc. issued an announcement, which is summarized as follows：
Helius Medical Technologies, Inc. announced that it has received a request for an additional information (“AI”) letter from the U.S. FDA related to the Company’s request for De Novo classification and 510(k) clearance of the PoNS?.
During the substantive review phase of a request for De Novo classification and 510(k) clearance, FDA may request additional information in order to obtain information necessary for the agency to continue or complete its review and, in such instances, places its review on hold until the requested information is submitted.
“We have enjoyed a good relationship with FDA in the development and review of our file. We believe we have the data and information to address FDA’s questions and we look forward to submitting our response to enable FDA to resume its review process as expeditiously as possible,” said Philippe Deschamps, Helius’ Chief Executive Officer. “We will continue to work towards securing clearance of PoNS.”
Mr. Deschamps continued: “The PoNS device is a novel technology and our pursuit of a clearance is focused on providing a solution for patients suffering from chronic balance deficit due to mild-to-moderate traumatic brain injury, a condition that impacts more than two million people in the United States. We understand and appreciate the thorough and detailed approach the FDA has taken to learn about our novel technology. We look forward to receiving clearance in the United States for our product.”
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