Australia’s TGA Grants Approval to First Objective Concussion Diagnostic
Oculogica, a medical device company and leader in concussion diagnosis and categorization, announced today the Therapeutic Goods Administration (TGA) of Australia granted approval to its EyeBOX technology. The test is for both pediatrics and adults. The technology is also patent protected in Australia.
Oculogica, Inc., a pioneer in algorithm-based neuro-diagnostics, announced that the Therapeutic Goods Administration (TGA) of Australia granted approval for the EyeBOX®, the first baseline-free tool to aid in the diagnosis of concussion on April 21, 2021. TBI Diagnostics is the Australian partner to Oculogica, and 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 the assessment of patients with suspected concussion via an easy-to-take, 4-minute test. Results of the pivotal DETECT clinical study of 282 patients who presented in the emergency room and concussion clinic with suspected traumatic brain injury (TBI) formed the basis of the Oculogica TGA application.
“We are thrilled to receive approval from TGA for the first baseline-free aid in the diagnosis of concussion. Until now, concussion assessments have relied on subjective measures or baseline testing. Physicians in the US are already relying on this technology. Australia is a very important market for concussion, given rugby and other sports are such a major national pastime. This authorization by TGA is a significant milestone for the company and, more importantly, heralds a new era for concussion diagnosis, categorization, and management for patients and healthcare practitioners,” said Oculogica CEO, Rosina Samadani, Ph.D.
TBI Diagnostics Chairman Stuart Duncan stated, “We have been waiting patiently for this approval and are thrilled to have it in hand. The Australian market now has the ultimate diagnostic tool to assist in the identification of concussions in an objective measured manner with this new cutting-edge technology.”
The pivotal DETECT study submitted to TGA enrolled 282 patients at six independent clinical sites in the United States and compared the EyeBOX results to a clinical reference standard for concussion in patients presenting to emergency departments and sports medicine clinics with a suspected head injury. The study showed that the EyeBOX had high sensitivity to the presence of concussion and that a negative EyeBOX result is consistent with a lack of concussion, thus providing objective data for healthcare providers to aid in the evaluation of patients with suspected TBI.
Several patents have been granted in Australia that cover the EyeBOX’s proprietary approach to concussion assessment using eye-tracking data, including non-spatial calibration which eliminates the need to calibrate the device and the need for a baseline, pre-injury, test.
The EyeBOX has marketing authorization in the US and Web Assisted Notification of Devices (WAND) approval in New Zealand.
About TBI Diagnostics
TBI Diagnostics was founded in 2019 with a vision of bringing to the Australasian marketplace cutting edge, technologically advanced brain trauma detection devices which ultimately lead the way in improving patient health and wellness outcomes.
The recent TGA approval of the EyeBOX as a class11a medical device has seen a vigorous surge in enquiries from all facets of the sporting, commercial, and first responder communities.
With the first TBI Diagnostic clinic in New Zealand having opened last month, last week’s TGA approval opens the door for the company’s first Australian land-based clinics and mobile response units to become operational shortly.
More on TBI Diagnostics can be found at www.tbid.com.au
Oculogica Inc. is an eye tracking-based, neuro-diagnostic company founded by Dr. Uzma Samadani, a neurosurgeon at Centracare and the Minneapolis Veterans Administration (VA) Medical Center, and Associate Professor of Bioinformatics and Computational Biology at the University of Minnesota School of Engineering. The company has developed the EyeBOX, the first and only FDA cleared baseline-free, aid in the diagnosis of concussion to help physicians objectively categorize concussion. EyeBOX is used by leading healthcare organizations, including Midwest Orthopedics at Rush University, the clinics of the President of the California Brain Injury Association, and others. To learn more about the company and the EyeBOX, visit www.oculogica.com.