Sway Medical's Concussion Management System Gains FDA Clearance

Feb 26, 2025
Sway Medical, Inc. has received FDA 510(k) clearance for its comprehensive concussion management system, integrating cognitive and balance testing into a single platform.

Sway Medical, Inc. has received FDA 510(k) clearance for its comprehensive concussion management system, announced in a press release. This clearance recognizes Sway as the first fully integrated tool combining both cognitive and balance testing for concussion management.

The system transforms any mobile device into a Class II medical device, utilizing patented algorithms and advanced motion analysis technology. This allows healthcare professionals to assess, track, and manage concussions with enhanced accuracy and efficiency. The platform aligns with the latest concussion management guidelines, providing a complete and objective approach to concussion care.

Sway Medical's solution is designed to fit seamlessly into medical workflows, offering a fast and easy-to-use tool for concussion assessment. With this FDA clearance, Sway Medical solidifies its position as a leader in digital health innovation, equipping healthcare professionals and sports organizations with cutting-edge tools for concussion management.

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