Sway Medical's Concussion Management System Gains FDA Clearance

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.

We hope you enjoyed this article.

Consider subscribing to one of several newsletters we publish like Life AI Weekly.

Also, consider following us on social media:

Subscribe to Life AI Weekly

Weekly coverage of AI applications in healthcare, drug development, biotechnology research, and genomics breakthroughs.

Whitepaper

Stanford HAI’s 2025 AI Index Reveals Record Growth in AI Capabilities, Investment, and Regulation

The 2025 AI Index by Stanford HAI provides a comprehensive overview of the global state of artificial intelligence, highlighting significant advancements in AI capabilities, investment, and regulation. The report details improvements in AI performance, increased adoption in various sectors, and the growing global optimism towards AI, despite ongoing challenges in reasoning and trust. It serves as a critical resource for policymakers, researchers, and industry leaders to understand AI's rapid evolution and its implications.

Read more