Certain products intended to aid in the assessment, diagnosis, or management of a head injury, which includes concussion, traumatic brain injury (TBI), and mild traumatic brain injury (mild TBI or mTBI) are considered medical devices regulated by the FDA.
CDRH recognizes that head injury is a major source of concern since the presence and severity of a head injury may not be readily assessable.
A noninvasive test that doesn’t require comparison with a baseline assessment before an injury occurred has received FDA approval to help diagnose concussion in children and adults.
Oculogica, Inc., a pioneer in algorithm-based neuro-diagnostics, announced today that the U.S. Patent and Trademark Office (USPTO) has issued the company a patent for a method of identifying patients using biometric information measured and captured by an eye tracking system. Identification of the patient may be performed by a cloud-based or local biometric service.
FDA Grants Marketing Authorization for Use in Children 5 and Older and Adults up to 67 Years of Age. January 3, 2019 — NEW YORK– Oculogica, Inc., a pioneer in algorithm-based neuro-diagnostics, announced that the U.S. Food and Drug Administration (FDA) granted their De Novo request for the commercialization of the EyeBOX® device, the first non-invasive, …
There is a growing body of evidence that concussion can impair eye movement. During the past seven years, clinician-scientists at Children’s Hospital of Philadelphia’s (CHOP) Center for Injury Research and Prevention (CIRP) have evaluated the utility of a visio-vestibular exam to detect deficits in concussed pediatric and adolescent patients, and the use of automated eye tracking technology to objectively measure these deficits.
Eye-tracking technology could help take the guesswork out of diagnosing brain injuries.
Allan May, Life Science Angels says, “This is a company that has done everything right.”
The Angel Capital Association is delighted to announce the four finalists for the Luis Villalobos Award, a highly regarded, North American-wide award that honors ingenuity, creativity and innovation among startups backed by ACA members: Catalyst OrthoScience, CNote, Oculogica and PhotoniCare.
As the Vikings prepare to play the Saints in the playoffs, Hall of Fame quarterback Brett Favre is making news for his comments about the last time the two teams met in the 2009 playoffs, telling KFAN radio about what he considers an undiagnosed head injury.