Sway Medical Inc. has received FDA 510(k) clearance for its Comprehensive Concussion Management System, a mobile-based solution designed to enhance concussion assessment and monitoring.

The system utilizes clinically validated balance and cognitive testing on a smartphone, enabling real-time, objective data collection for healthcare professionals, athletic trainers, and military personnel. Its cloud-based platform ensures seamless data tracking and decision support for improved patient care.

“This clearance marks a major milestone in concussion management, providing an accessible and scalable solution for objective testing,” said Chuck Bright, CEO of Sway Medical.

With this FDA approval, Sway Medical aims to expand adoption across sports, military, and clinical settings, reinforcing its commitment to advancing digital health solutions.