Aural Analytics Gets FDA Approval

The U.S. Food and Drug Administration (FDA) has registered Aural Analytics' Speech Vitals product as a computerized cognitive assessment aid, a class II software medical device (SaMD).

Aural Analytics built a quality management system (QMS) to meet FDA and other regulatory requirements. This QMS will allow Speech Vitals to become a routine vital sign in clinic and at home.

"Human speech relies on coordinating complex neural activity, including cognitive and motor functions," said Judy Smythe, CEO of Aural Analytics, in a statement. "As cognitive disease develops, subtle changes in speech occur, which can be precisely detected using our powerful speech analytics. Speech Vitals has tremendous potential and value in a clinical setting, aiding providers in early detection of cognitive conditions that can be challenging to distinguish, especially in early stages. Our FDA registration ensures a high standard in disease diagnosis through our validated speech metrics."

Speech Vitals collects just a few minutes of speech samples from patients via app-based tasks that measure speaking rate, articulatory precision, word search time, and other factors.

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