Sway Medical Sideline is an FDA-cleared 510(k) Class II Medical Device that reinvents concussion management by combining objective balance and cognitive testing into a single mobile tool. The platform is mobile-first, leveraging the built-in motion sensors (accelerometer) of any mobile device (iOS or Android) to measure stability and reaction time, eliminating the need for expensive, bulky hardware like force plates. It is designed for fast-paced sideline assessments, with screenings taking under 5 minutes, and baseline testing for entire teams in approximately 20 minutes.
Key Features and Capabilities include:
- Objective Testing: Offers over 40 validated tests across Balance (e.g., mBESS), Cognition (e.g., Reaction Time, Memory, Impulse Control), Function, and Surveys.
- Sideline Assessment: Combines on-field assessment (Red Flags, Maddocks Questions, Glasgow Coma Scale, Cervical Spine Assessment), symptom check, and objective balance/cognitive tests.
- Data & Reporting: Allows for quick comparison of current scores to an athlete's baseline and normative data, generating secure, comprehensive reports.
- Remote Testing: Administer tests remotely through the use of individual and group codes.
Target users include athletic trainers, team physicians, sports medicine professionals, physical therapists, primary care physicians, and neuropsychologists. Use cases extend beyond sports concussion management to include fall risk assessment, tracking recovery from injury, and detecting instability from medication changes in clinical settings. The platform is built to be HIPAA and FERPA compliant and is supported by a certified ISO 13485 quality system.