Concussion_FDA_12-28

FDA-cleared concussion assessment technology

Concussion assessment you can trust. Anywhere you need it.

Bring objective balance and cognitive testing to your Athletic Training program, right from a mobile device.

Healthy Roster Concussion, powered by Sway Sports+, combines mobile testing with FDA-cleared technology to support concussion assessment and management for individuals ages 12–28.

No testing hardware Team baselines in about 20 minutes Built for Athletic Trainers

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Get a short, personal demo to discover how mobile concussion assessment fits into your Athletic Training program.

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Sway Concussion Healthy Roster EMR

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What your staff gets

From baseline to return to play, all in one place

Mobile testing

Assess balance and cognitive function using a standard iOS or Android phone or tablet. No additional testing hardware required.

Faster baselines

Establish balance and cognitive baselines for an entire team in about 20 minutes, using group testing and athletes’ own devices.

Objective data

Compare post-injury results with an athlete’s baseline and age- and sex-matched normative data to support clinical evaluation.

Testing happens where the athlete is

On the sideline, in the training room, or in a room full of athletes testing at once — on the devices your program already has. Results land in the same athlete record your staff works in every day.

Sway app instruction screen: place feet together with eyes closed, with a Begin Test button. — Guided stance instructions for every test

Sway app instruction screen: the athlete holds the device against the chest and holds the stance while the test runs. — The athlete’s own device is the sensor

Sway results screen showing inspection time and reaction time scores against the athlete’s baseline range and percentile rank, with a Document in EMR action. — Results against baseline, ready to document

Clearance and evidence

FDA-cleared. Research-backed. Built for Athletic Trainers.

Healthy Roster Concussion utilizes Sway Sports+, an FDA-cleared Class II computerized cognitive assessment aid for concussion in individuals ages 12–28. Its latest FDA clearance is supported by extensive clinical evidence, including:

69,776Athletes included in annual baseline reliability research

752Diagnosed concussions included in clinical performance research

12–28FDA-cleared age range for Sway Sports+

Sway continues to invest in clinical research, regulatory compliance, and technology that helps Athletic Trainers care for their athletes with confidence.

The workflow

The tools you need, wherever you work

Whether you’re preparing for the season, evaluating an athlete after a suspected concussion, or monitoring recovery, Healthy Roster Concussion keeps your assessment information in one mobile platform.

1PreseasonBaseline testingEstablish individual balance and cognitive baselines.

2After a suspected injuryPost-injury assessmentCollect objective data alongside symptoms and other clinical findings.

3Through recoveryRecovery trackingFollow test results and symptoms over time to support return-to-play decisions.

See how it works

Better tools for more confident decisions

Discover how Healthy Roster Concussion brings mobile, objective balance and cognitive testing to your program today. Get a quick and personal demo to see how it works.

Get My Demo

Sway Sports+ is an FDA-cleared Class II computerized cognitive assessment aid for concussion, intended for use in individuals ages 12–28 when concussion or head injury is suspected. It provides objective data to aid qualified healthcare professionals in concussion assessment and management as part of a multimodal evaluation. Sway Sports+ does not diagnose concussion, determine its presence or absence, or provide diagnostic, treatment, or return-to-play recommendations. See Instructions for Use for indications, warnings, and precautions. Rx only.

510(k): K262000