Sway Medical, Inc. Announces FDA 510(k) Clearance of its Comprehensive Concussion Management System

TULSA, Okla., Feb. 26, 2025 /PRNewswire/ — 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.”

Key Benefits of Sway:

• Multi-Modal Concussion Testing – The only FDA-cleared mobile platform for both balance and cognitive assessment, aligning with modern concussion protocols and NCAA standards.
• Fast and Easy to Use – Sway is the only concussion management tool you can run from a mobile device, allowing it to fit easily into the medical professional’s workflow.
• Clinically Validated & Research-Backed – This 510(k) clearance provides further evidence of Sway’s extensive scientific research that clinicians can trust.

Looking Ahead

With this expanded FDA clearance, Sway Medical further demonstrates its place as the leader in concussion management, equipping healthcare professionals, athletic trainers, and sports organizations with the most complete and accessible concussion management tools. This clearance reaffirms Sway Medical’s leadership in digital health innovation and its mission to provide cutting-edge, evidence-based solutions that improve patient outcomes.

About Sway Medical, Inc.

Sway Medical, Inc. is a leading provider of mobile concussion management software that combines validated balance and cognitive testing into one platform. Utilizing patented technology that leverages the built-in sensors of any mobile device, Sway empowers healthcare professionals to deliver more accurate and efficient assessment tools in any environment.

For more information about Sway or to inquire about availability, please visit swaymedical.com.

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SOURCE Sway Medical