FDA Clears Neuro Kinetics’ Clinical Eye-Tracking Headset

Neuro Kinetics, Inc. (NKI), the global leader in clinical eye tracking and neural functional assessments, announced today that the United States Food and Drug Administration (FDA) has cleared its next breakthrough innovation, the I-Portal Portable Assessment System or I-PAS.
 
The I-PAS is an innovative, head-mounted, multi-modal system for use as a nystagmograph (vestibular and neurotologic diagnoses). It slips on and off as easily as a virtual reality headset, and is just as portable. Used for oculomotor and vestibular testing, the system integrates clinical eye tracking with a digital display to run a series of non-invasive tests while capturing the eye’s reflexes objectively and precisely using the latest USB-3 digital camera technology. FDA clearance covers fourteen OVRT (Oculomotor, Vestibular, and Reaction Time) tests, all of which exist on NKI’s other I-Portal platforms. In addition, I-PAS has the capacity to run tests that support research on concussions, drug effectiveness, and Parkinson’s disease, to name a few examples.
 
I-PAS strengthens NKI’s market-leading position in clinical eye-tracking technology and deepens its portfolio of FDA-cleared medical devices and tests. I-PAS’s compact, lightweight design and affordability offer superior convenience over traditional VNG systems. Like NKI’s other products, I-PAS delivers high quality diagnostic capability that helps evaluate patients with symptoms of dizziness and/or balance disorders that may be associated with such medical conditions as concussions, migraines, or BPPV (benign paroxysmal positional vertigo).
 
NKI’s ongoing commitment to science and engineering and to deliver the best in clinical eye tracking led to the development of I-PAS. Howison Schroeder, president and CEO of NKI, noted, “I-PAS’s portability, affordability, and ease of use is transformational for healthcare professionals who evaluate and treat concussion and vestibular patients, whether the setting is a physical therapy clinic, physician’s office, or sports field.”
 
Practitioners are eager for a device that objectively measures, reports, and monitors acute symptoms of concussions. Dr. Peter Doyle, Associate Medical Director of Health Services at Tufts University, added, “Most clinicians who care for concussed patients are aware that avoidance of re-injury prior to the complete resolution of a concussion is a hallmark of appropriate care. With the advent of NKI’s technology we finally have a means of accurately measuring an important set of symptoms and objectively knowing when they have resolved. In a treatment environment where patients often have incentive to either minimize or maximize their symptoms, this ability will transform the current standard of care.”
 
Shipments to fulfill existing orders of the new I-PAS begin in April. Additionally, I-PAS is being used in numerous research studies involving OVRT-C (the C stands for additional cognition tests) to assess the effectiveness of various drugs for concussion, as well as a measurement device in research on concussions in professional sports and the military. For an example, the 2016 article by Shannon Kelleher in The Atlantic, Can a Pill Replace Pot for Treating Concussions?.
 
Other recent publications include a study in PLOS ONE, and another in Laryngoscope Investigative Otolaryngology which shows OVRT-C tests using I-Portal technology correctly categorizes acute concussions and the ability to monitor those symptoms over time.