Helius Medical Technologies Inc has received Breakthrough Designation from the US Food and Drug Administration for its PoNS device as a temporary treatment of dynamic gait and balance deficits due to symptoms from stroke, it announces.
The device is designed for use as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over.
“We are very pleased to announce the receipt of Breakthrough Designation for our PoNS device to treat stroke-induced gait and balance deficits.
“Obtaining Breakthrough Designation represents an important milestone in our path to providing this underserved patient population with a non-drug, non-implantable treatment option that has the potential to significantly improve their gait and balance, their ability to walk and perform daily tasks. We look forward to building on this achievement by utilizing the Breakthrough Devices Program to facilitate our pursuit of US regulatory clearance for treatment of stroke-induced symptoms in close collaboration with the FDA.”
— Helius CEO, Dane Andreeff
Breakthrough Device Program
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.
The Breakthrough Devices Program offers manufacturers such as Helius an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission, per the release.
[Source(s): Helius Medical Technologies Inc, Globe Newswire]