Years ago, after witnessing the anxiety and uncertainty around ADHD diagnosis and its treatment, we decided to do something to help the patients and families affected by this broadly identified, yet narrowly understood condition. We started with an objective test, creating the first and only brainwave based assessment aid for ADHD and achieving FDA clearance on this method to take the guesswork out of diagnosis. For 15 years, we’ve pursued brain health with a passion. Our hope is that children and adults can maintain and promote their brain health with our products and services. We’ve developed our core line of supplements after extensive research into their benefits and avoided any artificial colors or flavors. We’ve remained small, answering to ourselves and to the physicians and families who believe in our cause. Our promise is to keep working. Our mission is happy, healthy brains.
We are an ISO13485 medical device manufacturer and a dietary supplement formulator, packager and distributor with an FDA facility in Boulder, Colorado and corporate offices in Augusta, Georgia. We operate a registered HIPAA compliant NIEA physiological laboratory and are a member of AdvaMed and support the AdvaMed Code of Ethics.
Product development clinical studies
Steve Snyder and Howard Merry begin meeting with FDA about an EEG-based ADHD assessment aid
NEBA Health formed – Current team in place including regulatory, engineering, accounting, management
FDA and NEBA develop study design for validating an EEG-based biomarker. FDA requires class III Pre-Market Approval (PMA) study, a multisite validation study with independent data custodian. First patient enrolled in NEBA FDA PMA multisite validation study
NEBA begins filings with FDA for PMA including clinical data
NEBA is cleared to market in the EU and Canada with CE marking and Health Canada licensing
Our small team achieves the unthinkable – NEBA Health wins FDA clearance for NEBA – makes national news. FDA issues press release. K112711 – First EEG-Based device cleared by FDA to aid in the assessment of a psychiatric disorder. In partnership with NEBA Health, FDA creates a new device category to regulate EEG-based Neuropsychiatric diagnostic devices. CFR 882.1440 First NEBA patient
Since 2014 NEBA is used by hundreds of clinicians with thousands of patients evaluated
NEBA begins to research therapeutics – starts research on Omega-3 fatty acids for brain health
NEBA health begins nutraceutical operations