Sway Medical Wins FDA Nod for Concussion Management System

Sway Medical, the company that created the mobile concussion management category, has received U.S. Food and Drug Administration (FDA) 510(k) clearance as a computerized cognitive assessment aid for concussion.

The FDA nod builds on the company’s prior clearance for balance testing in head injuries. It officially recognizes Sway as the first fully integrated tool that merges cognitive and balance testing into one concussion management product.

Sway transforms mobile devices (iOS and Android) into a Class II medical device that uses patented algorithms and advanced motion analysis tech. The platform spots subtle changes in patient performance after a concussion so clinicians can assess-track, and manage concussions.

The company said the expanded FDA clearance solidifies its place as a leader in concussion management, giving healthcare professionals, athletic trainers, and sports organizations a complete and accessible set of concussion management tools.

Sway’s clearance under CFR21.882.1471 has rewritten the standard for concussion management tools to align with NCAA and consensus standards that include balance and cognitive assessment in athletes with suspected concussion.

“This FDA clearance is an important milestone, not because it validates our technology for the first time, but because it officially recognizes what we’ve already demonstrated in clinical practice,” said Chase Curtiss, founder of Sway Medical. “We have always provided a validated, research-backed solution for concussion assessment. Now, with FDA clearance for both balance and cognitive testing, Sway can claim the only comprehensive tool in line with the latest concussion management guidelines.”