The US Food and Drug Administration (FDA) is seeking additional information (AI) related to Helius Medical Technologies request for De Novo classification and 510(k) clearance of the Portable Neuromodulation Stimulator (PoNS) device.
Helius Medical said that during the substantive review phase of a request for De Novo classification and 510(k) clearance, the US regulator may request for further information to obtain all the necessary information needed to continue or complete its review.
In such cases, the review will be placed on hold until the requested information is submitted.
Helius Medical CEO Philippe Deschamps said the company has 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.
Deschamps said: “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 non-invasive treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury.”
Earlier this month, the company partnered with New Jersey-based Kessler Institute for Rehabilitation and Kessler Foundation, to conduct the fourth Clinical Experience Program (CEP) for its PoNS. It is a licensed class II medical device in Canada and is being investigated in the US and in the EU.
Such CEPs enable the company to investigate under a clinical setting, its PoNS treatment in patients with chronic balance deficit due to mild-to moderate-traumatic brain injury (mTBI).
The company also partnered with Oregon Health & Science University (OHSU) in Portland, Oregon to conduct a CEP.
Last month, it submitted application for CE Marking for the PoNS device, which will allow to sell the product in the European Union.