Speciality Medical Dialogues
    • facebook
    • twitter
    Login Register
    • facebook
    • twitter
    Login Register
    • Medical Dialogues
    • Education Dialogues
    • Business Dialogues
    • Medical Jobs
    • Medical Matrimony
    • MD Brand Connect
    Speciality Medical Dialogues
    • Editorial
    • News
        • Anesthesiology
        • Cancer
        • Cardiac Sciences
        • Critical Care
        • Dentistry
        • Dermatology
        • Diabetes and Endo
        • Diagnostics
        • ENT
        • Featured Research
        • Gastroenterology
        • Geriatrics
        • Medicine
        • Nephrology
        • Neurosciences
        • Nursing
        • Obs and Gynae
        • Ophthalmology
        • Orthopaedics
        • Paediatrics
        • Parmedics
        • Pharmacy
        • Psychiatry
        • Pulmonology
        • Radiology
        • Surgery
        • Urology
    • Practice Guidelines
        • Anesthesiology Guidelines
        • Cancer Guidelines
        • Cardiac Sciences Guidelines
        • Critical Care Guidelines
        • Dentistry Guidelines
        • Dermatology Guidelines
        • Diabetes and Endo Guidelines
        • Diagnostics Guidelines
        • ENT Guidelines
        • Featured Practice Guidelines
        • Gastroenterology Guidelines
        • Geriatrics Guidelines
        • Medicine Guidelines
        • Nephrology Guidelines
        • Neurosciences Guidelines
        • Obs and Gynae Guidelines
        • Ophthalmology Guidelines
        • Orthopaedics Guidelines
        • Paediatrics Guidelines
        • Psychiatry Guidelines
        • Pulmonology Guidelines
        • Radiology Guidelines
        • Surgery Guidelines
        • Urology Guidelines
    LoginRegister
    Speciality Medical Dialogues
    LoginRegister
    • Home
    • Editorial
    • News
      • Anesthesiology
      • Cancer
      • Cardiac Sciences
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endo
      • Diagnostics
      • ENT
      • Featured Research
      • Gastroenterology
      • Geriatrics
      • Medicine
      • Nephrology
      • Neurosciences
      • Nursing
      • Obs and Gynae
      • Ophthalmology
      • Orthopaedics
      • Paediatrics
      • Parmedics
      • Pharmacy
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
    • Practice Guidelines
      • Anesthesiology Guidelines
      • Cancer Guidelines
      • Cardiac Sciences Guidelines
      • Critical Care Guidelines
      • Dentistry Guidelines
      • Dermatology Guidelines
      • Diabetes and Endo Guidelines
      • Diagnostics Guidelines
      • ENT Guidelines
      • Featured Practice Guidelines
      • Gastroenterology Guidelines
      • Geriatrics Guidelines
      • Medicine Guidelines
      • Nephrology Guidelines
      • Neurosciences Guidelines
      • Obs and Gynae Guidelines
      • Ophthalmology Guidelines
      • Orthopaedics Guidelines
      • Paediatrics Guidelines
      • Psychiatry Guidelines
      • Pulmonology Guidelines
      • Radiology Guidelines
      • Surgery Guidelines
      • Urology Guidelines
    • Home
    • Latest News
    • FDA approves first non...

    FDA approves first non invasive test for diagnosing concussion

    Written by Dr. Kamal Kant Kohli Kohli Published On 2019-01-03T19:30:08+05:30  |  Updated On 3 Jan 2019 7:30 PM IST
    FDA approves first non invasive test for diagnosing concussion

    The Food and Drug Administration (FDA) has granted marketing permission for first non-invasive, baseline-free aid in diagnosis of concussion.EyeBOX (Oculogica),is easy to use test that collects and analyzes over 100,000 data points to generate an objective assessment that is unique to each patient.It can be used as aids in the diagnosis of concussion in patients 5 to 67 years of age.


    Oculogica plans to market the device for use in pediatrics ages 5 and older and adults up to 67 years of age, starting with a pilot launch for select, qualified sites. EyeBOX uses eye-tracking to provide objective information to aid in assessment of patients with suspected concussion via an easy to take, 4-minute test. A binocular camera then tracks each eye and gathers data that ultimately leads to a score that rates the severity of brain injury; a score ≥10 is Oculogica's threshold for concussion.


    The FDA approval was supported by results from the DETECT clinical study which included 282 patients with suspected traumatic brain injury. Results showed that compared with a clinical reference standard for concussion, EyeBox had high sensitivity to the presence of concussion; a negative result was consistent with a lack of concussion.


    Oculogica’s extensive clinical research and validation have shown we can provide an objective assessment to healthcare providers when evaluating patients with suspected mild traumatic brain injury,” said Rosina Samadani, Ph.D., CEO of Oculogica. “We are thrilled to receive marketing authorization from FDA for the first non-invasive, baseline-free aid in diagnosis of concussion. This field is a challenging one. Several key aspects of a diagnostic have thus far eluded researchers. Before now, concussion assessments have relied on subjective measures or baseline testing. This authorization by FDA is a significant milestone for the company and, more importantly, heralds a new era for concussion diagnosis and management for patients and healthcare practitioners.”


    “This is an important achievement for the field, which has had to work with the lack of objective measures until now. The EyeBOX as part of an objective, multimodal assessment will eventually be the new state of the art, which will be an important advance for patients,” stated Dr. Christina Master, professor of clinical pediatrics at the University of Pennsylvania and attending physician at the Children’s Hospital of Philadelphia.


    Eye-tracking will change the practice of emergency care for concussion and will greatly assist a large number of patients," said Dr Robert Spinner, Chair of the Department of Neurological surgery at Mayo Clinic. "The result will be more consistent and objective diagnoses of concussion in the emergency room and clinic, and eventually on the field.”







    baseline-freeDETECT clinical studydiagnosis of concussiondiagnostic aidEyeBOXFDAnon-invasiveThe Food and Drug AdministrationUS

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Dr. Kamal Kant Kohli Kohli
    Dr. Kamal Kant Kohli Kohli
      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND

      • Email: info@medicaldialogues.in
      • Phone: 011 - 4372 0751

      Website Last Updated On : 12 Oct 2022 7:06 AM GMT
      Company
      • About Us
      • Contact Us
      • Our Team
      • Reach our Editor
      • Feedback
      • Submit Article
      Ads & Legal
      • Advertise
      • Advertise Policy
      • Terms and Conditions
      • Privacy Policy
      • Editorial Policy
      • Comments Policy
      • Disclamier
      Medical Dialogues is health news portal designed to update medical and healthcare professionals but does not limit/block other interested parties from accessing our general health content. The health content on Medical Dialogues and its subdomains is created and/or edited by our expert team, that includes doctors, healthcare researchers and scientific writers, who review all medical information to keep them in line with the latest evidence-based medical information and accepted health guidelines by established medical organisations of the world.

      Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription.Use of this site is subject to our terms of use, privacy policy, advertisement policy. You can check out disclaimers here. © 2025 Minerva Medical Treatment Pvt Ltd

      © 2025 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X
      We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok