FDA Registers Aural Analytics Clinical-Grade Speech Analytics as a Computerized Cognitive Assessment Aid

Aural Analytics obtains FDA registration to improve the standard of care and lead the way for speech analytics in clinical settings

PHOENIX–(BUSINESS WIRE)–#AidAural Analytics, Inc., a leader in clinical-grade speech analytics, today announced US Food and Drug Administration (FDA) registration for its clinical-grade speech analytics product, Speech Vitals, as a computerized cognitive assessment aid, a class II software medical device (SaMD). FDA registration strengthens Speech Vitals’ objective, reliable, generalizable, and repeatable approach to speech analytics, made possible by its clinically and analytically validated measures of speech.

Aural Analytics built a quality management system (QMS) to meet FDA and other regulatory requirements. This QMS sets an even higher standard of care that will allow Aural Analytics’ speech collection app, 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. “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 many others. These metrics serve the purpose of assessing cognitive conditions. Speech as a vital sign reduces the patient burden, as it is collected through a user-friendly app that can be deployed on any device in-clinic or at home. Speech Vitals is SDK-ready and can be embedded into provider and healthcare system applications, ensuring seamless integration into a clinician’s everyday practice.

About Aural Analytics, Inc.

Aural Analytics is the industry’s leading speech neuroscience company harnessing the clinical utility of the world’s speech across the age range and around the world. Their suite of applications and embeddable SDKs and APIs are available in more than 25 languages across Android, iOS, and the web and are easy to use, secure, and provide robust, clinically relevant, interpretable, and validated metrics reflecting the neurological and respiratory health of its users. For more information, please visit auralanalytics.com or follow Aural Analytics on Twitter, LinkedIn, Medium, and Facebook.


Paulo Acuña



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