ElMindA Ltd. announced today that the United States Food and Drug Administration (FDA) has cleared the company's BNA™ Analysis System for the assessment of brain function. Brain Network Activity (BNA™) combines non-invasive, multi-channel EEG technology with sophisticated signal processing and analysis algorithms to measure patterns of brain networks activated during specific brain processes and deliver both quantitative and qualitative insights into brain functionality. The BNA™ output allows healthcare providers to assess a patient's functional brain network activity and compare it with functional network activity of healthy brains. BNA™ is currently cleared for 14 to 24 year-olds, and the company is conducting additional research activities to further expand the indicated age group.
"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."
"BNA™ allows physicians to assess brain health using objective neurological measurements," said Jeffrey S. Kutcher, M.D., associate professor of neurology, 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 established a growing database of brain activity from both healthy subjects and patients with brain-related disorders. The database currently includes more than 7,000 BNA™ datasets, which provide a robust, clinically supported foundation to potentially help identify and manage neurological disorders such as ADHD or pain, and brain injuries such as concussion. Prominent clinical institutions across the country are leading research studies focused on the use of BNA™ across several of these areas.