FDA Clears First Computerized Cognitive Test For Concussion

The FDA has for the first time cleared a computerized diagnostic device designed specifically to evaluate a patient’s cognitive function immediately following a head injury and a suspected traumatic brain injury (TBI), otherwise known as concussion. While the Immediate Post-Concussion Assessment and Cognitive Testing (imPACT) device cannot conclusively diagnose TBI on its own, or direct a course of treatment, the tool offers point-of-care quantitative evaluation to assist trained healthcare providers in making treatment decisions.

Traditional TBI testing is dependent on subjective evaluations by trained medical clinicians, and it relies heavily on an individual’s judgement. However, recent TBI research has been investigating more quantitative concussion assessments, which would provide more consistent and reliable results. The FDA recently hosted a public workshop where it invited experts from the industry and academia to discuss the latest in biomarker and big data analytics research related to TBI.

Banyan Biomarkers, a medtech that attended the FDA’s workshop, is working in collaboration with Philips towards a diagnostic device that tests the blood for evidence of TBI. NYU researchers recently introduced eye-tracking technology built into an automated computer program, and Neural Analytics, a startup based in California, has developed an ultrasound headset that could recognize concussions on the sidelines of sporting events.

imPACT’s device is the first technology of its kind to be cleared for U.S. markets through de novo classification, according to a company press release. Using a range of cognitive tasks for patients with suspected concussion, the imPACT device “will aid in the assessment and management of concussion,” stated the FDA.

“imPACT’s FDA clearance is a huge step forward for the industry, for athletes and others who are at risk of concussion-related injuries, as well as for licensed, trained medical professionals everywhere,” said Michael Wahlster, CEO of imPACT Applications.

In order to secure marketing permission, imPACT submitted over 250 studies, half of which were conducted by third-party organizations. Data collected in these studies provided valid scientific evidence of the device’s reliability, safety, and effectiveness, according to the agency, while warning that the device was not meant to be used on its own.

“These devices provide a useful new tool to aid in the evaluation of patients experiencing possible signs of concussion, but clinicians should not rely on these tests alone to rule out a concussion or determine whether an injured player should return to the game,” said Carlos Peña, director of the division of neurological and physical medical devices at the FDA’s Center for Devices and Radiological Health (CDRH), in a statement.

The U.S. Centers for Disease Control and Prevention (CDC) estimate that TBI represents 30 percent of injury-related deaths reported each year and accounts for 2.5 million emergency room visits.

In March, Abbott teamed with Minnesota researchers to launch the largest ever single-centered TBI study, which will investigate a range of possible TBI diagnostics, including digitized eye-tracking technology, blood-based biomarkers, and MRI techniques.