The company's Ahead 300 device secured approval from the US Food and Drug Administration (FDA) in September 2016.
The device will enable clinicians to assess mild head-injured patients across the full spectrum of brain injury.
It features four objective tests and 16 standard concussion assessment tools that can be customized on the handheld device into a configurable panel.
The first two tests, which are based on EEG and BrainScope’s proprietary methodologies, will help to determine abnormalities related to mild traumatic brain injury.
The other two tests will enable clinicians to evaluate patient performance compared to healthy individuals in the same age group.
In addition, the clinicians can use multiple professional society-based concussion assessment tools, as part of the clinical practice.
BrainScope will initially supply the new medical device to the select group of customers, including urgent care clinics, concussion clinics, emergency medicine departments, and university and professional Sports.
The company will also provide Ahead 300 products to various branches of the US military and government.
BrainScope CEO Michael Singer said: “Following an eight year evolution of development, which included 4 FDA clearances, we are announcing today the launch of the Ahead 300 for sale.
“The Ahead 300 offers a multi-modal, comprehensive capability to address a vast market need for the epidemic of mild head injury in this country.”
Image: The Ahead 300 device enables clinicians to assess mild head injury such as concussion. Photo: courtesy of Business Wire.
