Brainscope said today that it won FDA 510(k) clearance for its next-gen Ahead 300 traumatic brain injury assessment device, developed through a partnership with the U.S. Defense Dept.
The Bethesda, Md.-based company’s Ahead 300 is designed to provide multiple clinically relevant measures for assessing traumatic brain injury, including concussions. The new version will also be the 1st the company will look to sell commercially.
“FDA clearance of the Ahead 300 is a bellwether moment in our company’s history. The Ahead 300 provides the specific capabilities needed today for the clinician to undertake a comprehensive assessment addressing the full spectrum of traumatic brain injury, from structural injuries visible on a CT scan, through mild TBI, also known as concussion. Our FDA clearance represents many years of development with our partner, the Dept. of Defense. We are particularly grateful for the strong, continuing partnership which has led to this outstanding outcome. We are now preparing to commercialize the Ahead 300, which we expect to be available in the coming months. We will be making a formal announcement upon our commercial launch of the Ahead 300,” CEO Michael Singer said in a press release.
The newly cleared Ahead 300 features electroencephalography capabilities which use algorithms and machine learning to provide TBI analysis. The unit includes disposable electrode headsets and can provide additional assessments which can be delivered in a digitized reports.
“The BrainScope platform is a desperately needed addition to the medical provider’s clinical armamentarium. With mild TBI as prevalent as it is, an objective easy-to-use point of care device to identify those patients at highest risk of concussion is a critical need,” Dr. Geoffrey Ling said in prepared remarks.
BrainScope said it has received over $27 million through research contracts from the Defense Dept. for research on the Ahead system.
In August, BrainScope announced a number of new assignments to its executive roster, assigning 4 new picks to its c-suite. The neurotech company picked up Dr. Leslie Prichep as chief scientific officer, Kerstin Schultz as president and COO, Angad Singh as chief technology officer, and promoted Laurie Silver to CFO.