ElMindA Announces FDA Clearance of BNA™ Analysis System
ElMindA Ltd. of Herzliya, Israel, announced 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 advanced brain analysis and mapping technology enables assessment of brain health based on objective neurophysiological measures. 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 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 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.
Founded in 2006 to address an unmet need in the accurate, objective diagnosis and treatment of brain-related disorders, ElMindA is pioneering 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.