Oculogica, Inc., a pioneer in algorithm-based neuro-diagnostics for brain health, announced today that the American Medical Association (AMA) has confirmed the addition of a new Category 3 CPT Code, 0X17T, Eye movement analysis test without spatial calibration, allowing clinicians to appropriately report the services related exclusively to the Oculogica EyeBOX® exam.
FDA: The FDA Recommends Only Using Cleared or Approved Medical Devices to Help Assess or Diagnose a Head Injury, Including Concussion: FDA Safety Communication
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.
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.
Oculogica Receives FDA Marketing Authorization for EyeBOX® Device, the First Non-Invasive, Baseline-Free Test for Concussion
FDA Grants Marketing Authorization for Use in Children 5 and Older and Adults up to 67 Years of Age. January 3, 2019 — NEW YORK– …
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.
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