Aurora Concussion Therapy Systems Inc (Aurora – CTS) announces that the United States Food and Drug Administration (FDA) has designated its Aurora Light Therapy System as a Breakthrough Device under FDA’s Expedited Access Pathway.
“This designation accelerates our goal of bringing to market a solution that may greatly improve the recovery from a concussion. We look forward to continuing to work closely with the FDA through this process,” says Doug Devens, Chief Technology Officer of Minnesota-based Aurora – CTS, in a media release.
The Aurora Light Therapy System device is designed to apply a non-invasive, near infrared light to energize the brain’s metabolic cascade process and accelerate the healing process for concussions and other mild brain trauma.
The company currently is completing its GLP animal safety trials to support the upcoming initiation of its human clinical trials and intends to commence its first planned clinical trials in the near future to demonstrate safety in humans and to record the clinical effects relating to the recovery time for concussion patients.
The goal of the FDA’s Breakthrough Devices Program is to provide patients and health care providers with timely access to 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.
[Source(s): Aurora Concussion Therapy Systems Inc, PR Newswire]