FDA Clears ElMindA Brain Analysis System

Brain assessment technology company ElMindA Ltd. has received U.S. Food and Drug Administration (FDA) clearance to market the BNA Analysis System, a noninvasive device that uses EEG technology and signal processing to provide glimpses of the brain at work.

The system currently is designed for 14- to 24-year-olds, and the Israeli devicemaker is doing additional tests to support a broader age range.

“Greater understanding of how our brain processes information, how it gets its job done, ultimately holds the potential to improve brain health and disease management over a person’s lifetime,” said Ronen Gadot, CEO of ElMindA. “BNA adds an objective layer of information to clinical symptom assessments and neurocognitive tests, providing clinicians with a comprehensive view of brain health.”

The BNA system uses algorithms to measure patterns of brain networks activated during specific brain processes and compares that with activity seen in healthy brains.

“BNA allows physicians to assess brain health using objective neurological measurements,” said Jeffrey S. Kutcher, M.D., associate professor of neurology at the University of Michigan Medical School. “This will allow those of us caring for patients the ability to more clearly differentiate a healthy brain from one affected by disease or injury, and potentially have more informed discussions about lifestyle, activity, prevention and treatment decisions as a result.”

ElMindA has a database of over 7,000 BNA datasets of brain activity from healthy patients and those with brain-related disorders. It will help in identifying and managing disorders such as attention deficit hyperactivity disorder and concussions, the company said.

Founded in 2006, ElMindA develops brain assessment technologies designed to inform critical decisions by providing a clear view of brain function over time. The company uses a data-driven approach to transform algorithmic science and neuroscience expertise into routine clinical practice, and is a preferred partner of industry-leading organizations based on the rigor of its science and technology development.