FDA grants marketing authorization to concussion tool
The FDA recently granted Oculogica marketing authorization for its EyeBOX concussion test, the first noninvasive, baseline-free tool to assist in diagnosing concussions, according to a company press release.
The tool uses eye-tracking to confirm or deny suspected concussions in 4 minutes, the company stated.
“Eye-tracking will change the practice of emergency care for concussion and will greatly assist a large number of patients. The result will be more consistent and objective diagnoses of concussion in the emergency room and clinic, and eventually on the field,” Robert Spinner, MD, and chair of the neurological surgery department at Mayo Clinic, said in a press release.
A study that involved 282 patients in EDs and concussion clinics showed that EyeBOX’s novel eye tracking algorithm had high sensitivity to the presence of concussion and that a negative EyeBOX result was consistent with no concussion. This study formed the basis of Oculogica’s application, according to the company.
“Oculogica’s extensive clinical research and validation have shown we can provide an objective assessment to health care providers when evaluating patients with suspected mild traumatic brain injury,” Rosina Samadani, PhD, CEO of Oculogica said in the release. “Before now, concussion assessments have relied on subjective measures or baseline testing. This authorization by FDA ... heralds a new era for concussion diagnosis and management for patients and health care practitioners.”
EyeBOX is intended for patients aged 5 to 67 years. A pilot launch is scheduled for certain qualified sites, according to the company.
Disclosures: Samadani works for Oculogica. Healio Family Medicine was unable to determine Spinner’s relevant financial disclosures prior to publication.