[Tulsa, OK] – [February 21, 2025] – Sway Medical, Inc., the company that created the Mobile Concussion Management category, is proud to announce that it has received FDA 510(k) clearance as a Computerized Cognitive Assessment Aid for Concussion under Section 882.1471. This clearance expands on Sway Medical’s previous FDA clearance for balance testing in head injuries, officially recognizing Sway as the first fully integrated tool that combines both cognitive and balance testing into one product for concussion management.
This milestone reinforces Sway’s commitment to delivering clinically validated, real-world solutions for concussion assessment, aligning with the latest Concussion in Sport Group Consensus Statement, which highlights multi-modal testing as the gold standard for concussion care.
Advancing Concussion Management with an All-in-One Solution
Concussions are complex injuries requiring a multi-faceted approach to assessment. While many existing tools focus only on cognitive testing, Sway combines balance and cognitive evaluations in a single, FDA-cleared platform, providing a complete and objective approach to concussion care.
Sway transforms any mobile device into a Class II medical device that leverages patented algorithms and advanced motion analysis technology. This innovative platform detects subtle changes in patient performance following a concussion, enabling healthcare professionals to assess, track, and manage concussions with greater accuracy and efficiency.
“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, Inc. “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.”
