FDA Grants Breakthrough Status To Altoida For Computerized Predictive Alzheimer’s Disease Assessment

The U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation status to Altoida, Inc. for its computerized cognitive assessment aid, Digital Neuro Signature (DNS). The assessment tool can predict if an older adult with mild cognitive impairment (MCI) will meet diagnostic criteria for Alzheimer’s disease within 12 months. The assessment is intended for use with people age 55 and older who have been diagnosed with MCI.

Altoida’s Digital Neuro Signature (DNS) is a longitudinal cognitive test consisting of two active digital biomarker metrics. It gives results in 10 minutes compared to conventional neuropsychological assessments that take . . .