* CogniFit assessments are intended as a screening tools for detecting cognitive decline or alterations in an effort to allow physician directed therapeutic intervention to occur. In a clinical setting, the CogniFit results (when interpreted by a qualified healthcare provider), may be used as a screening aid to assist in determining whether or not a particular individual should be referred for further neuropsychological evaluation (e.g., a complete neuropsychological exam). CogniFit does not directly offer a medical diagnosis of any type. A diagnosis of ADHD, dyslexia, dementia, or similar disease can only be made by a qualified physician or psychologist considering a wide range of potential contributing factors. Consistent with this stated intended use, CogniFit assessments tools have no indication that are or should be considered a Medical Device by the FDA.
The product may also be used for research purposes for any range of cognitive related assessments. If used for research purposes, all use of the product must be in compliance with appropriate human subjects' procedures as they exist within the researchers' institution and will be the researcher's obligation. All such human subject protections will under no circumstances be less than those required to be afforded to research subjects under the provisions of Section 45 CFR 46 of the Code of Federal Regulations.