Sam Brusco, Associate Editor03.30.23
Aural Analytics, a developer of clinical-grade speech analytics, has gained breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its Speech Vitals – ALS technology.
Speech Vitals – ALS is a software application that collects and analyzes speech recordings to help neurologists monitor amyotrophic lateral sclerosis (ALS) in adults in both the home and clinic environments. Currently, very few devices used for ALS treatment hold breakthrough status.
“Achieving breakthrough designation for Speech Vitals - ALS is explicit validation that the FDA sees the potential in the Speech Vitals platform to provide for more effective management of this devastating disease,” Jeremy Moore, Director of Quality Assurance & Regulatory Affairs at Aural Analytics told the press. “We look forward to working closely with the agency to continue to develop our platform to achieve De Novo clearance to get it into the hands of the physicians and patients that need it the most.”
Speech Vitals collects a few minutes of speech from patients through app-based tasks that measure speaking rate, articulatory precision, phonatory duration, and other metrics that serve to purpose of evaluating speech-motor conditions. Using speech as a vital sign reduces patient burden according to the company, because it’s collected through a user-friendly app that can be deployed on any device in the clinic or at home. The tech is SDK-ready and can be integrated into provider and healthcare system applications.
Aural Analytics aims to pursue further indications for the technology, including diagnosis. Once Speech Vitals gains regulatory clearance, the tech will be applied to further conditions that impact speech, like Parkinson’s disease.
Speech Vitals – ALS is a software application that collects and analyzes speech recordings to help neurologists monitor amyotrophic lateral sclerosis (ALS) in adults in both the home and clinic environments. Currently, very few devices used for ALS treatment hold breakthrough status.
“Achieving breakthrough designation for Speech Vitals - ALS is explicit validation that the FDA sees the potential in the Speech Vitals platform to provide for more effective management of this devastating disease,” Jeremy Moore, Director of Quality Assurance & Regulatory Affairs at Aural Analytics told the press. “We look forward to working closely with the agency to continue to develop our platform to achieve De Novo clearance to get it into the hands of the physicians and patients that need it the most.”
Speech Vitals collects a few minutes of speech from patients through app-based tasks that measure speaking rate, articulatory precision, phonatory duration, and other metrics that serve to purpose of evaluating speech-motor conditions. Using speech as a vital sign reduces patient burden according to the company, because it’s collected through a user-friendly app that can be deployed on any device in the clinic or at home. The tech is SDK-ready and can be integrated into provider and healthcare system applications.
Aural Analytics aims to pursue further indications for the technology, including diagnosis. Once Speech Vitals gains regulatory clearance, the tech will be applied to further conditions that impact speech, like Parkinson’s disease.