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Israeli Company Gets FDA Approval for Pioneering Brain-Analysis System

The United States Food and Drug Administration (FDA) has given its approval for a pioneering, noninvasive brain-function analysis system from the Israeli company ElMindA for 14- to 24-year-olds, and ElMindA is conducting additional research activities to further expand the indicated age group.

The company’s Brain Network Activity (BNA) system combines noninvasive, 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.

“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 ElMindA CEO Ronen Gadot. “BNA adds an objective layer of information to clinical symptom assessments and neurocognitive tests, providing clinicians with a comprehensive view of brain health.”

ElMindA, founded in 2006, 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 that provide a clinically supported foundation for helping to identify and manage neurological disorders such as ADHD, depression, Alzheimer’s disease or pain, and brain injuries such as concussion. “BNA allows physicians to assess brain health using objective neurological measurements,” said Dr. Jeffrey S. Kutcher, 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.” (via Israel21c)

The BNA system was one of four Israeli technologies demonstrated this year at AIPAC’s Innovation Showcase.

ElMindA at AIPAC Innovation Showcase from Elminda on Vimeo.

[Photo: Prime-do / Googleimages]