Anyone who has played a contact sport knows the danger of a concussion. The FDA has recently given De Novo approval to a device that could change how concussions are diagnosed.
The Eyebox is a new device that uses eye-tracking technology to assess whether a patient has a concussion – a more objective measure than the current assessment method, experts say.
How it works
The device, developed by Oculogica, tracks eye movements while a patient watches a four-minute video and then uses an algorithm to determine the existence and scope of a concussion.
A recent study of 282 patients who came to emergency rooms or clinics with suspected traumatic brain injury found that Eyebox can detect the presence of a concussion.
In addition, the device also will provide a negative reading that shows the lack of a concussion. This is especially valuable to players in contact sports who may have suffered a head trauma but want to rejoin competition as soon as possible. Oculogica officials say many players have learned how to act and answer questions so they can avoid a concussion diagnosis and can continue play.
How to diagnose a concussion
The current method of diagnosing a concussion is largely subjective and has no baseline.
Concussion symptoms may not appear for hours after the incident. The physician will test cognitive ability with questions to evaluate memory, concentration, and ability to recall information.
The physician will also conduct a neurological exam to evaluate:
- Vision
- Hearing
- Sensation
- Balance
- Coordination
- Reflexes
If the patient shows severe headaches, swelling, vomiting or seizures, the physician may order a CT scan or MRI scan of the brain.
Eyebox officials also say the device’s use might be expanded to include diagnosis of other neurological conditions.
The FDA offers De Novo classification to devices that can show their possibilities but are so new that no previous product can be held as an example of effectiveness.
