FDA Grants Breakthrough Device Designation to Aural Analytics for Speech Analytics Software to Be Used in Treatment of ALS

March 29, 2023 |

2 min read

Aural Analytics, Inc.today announced that its Speech Vitals - ALS technology has been granted designation as a Breakthrough Device by the US Food and Drug Administration (FDA).

SCOTTSDALE, Ariz.--(BUSINESS WIRE)-- Aural Analytics, Inc., a leader in clinical-grade speech analytics, today announced that its Speech Vitals - ALS technology has been granted designation as a Breakthrough Device by the US Food and Drug Administration (FDA). Speech Vitals - ALS is a software application used in the collection and analysis of speech recordings to assist neurologists in the monitoring of amyotrophic lateral sclerosis (ALS) in adults in both clinic and home environments.

The Breakthrough Device Designation is currently held by fewer than 800 devices, of which less than 140 are intended for neurological disorders and even fewer are used for ALS treatment. Medical devices receive breakthrough designation from the FDA when they provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the program is to provide patients and healthcare providers with timely access to groundbreaking technologies by expediting the approval process.

“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,” said Jeremy Moore, Director of Quality Assurance & Regulatory Affairs at Aural Analytics. “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 just a few minutes of speech samples from patients via app-based tasks that measure speaking rate, articulatory precision, phonatory duration and many other metrics. These metrics serve the purpose of assessing speech-motor 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.

Aural Analytics intends to pursue additional indications using Speech Vitals - ALS, to include diagnosis. Once Speech Vitals achieves regulatory clearance, the technology will be applied to additional conditions that impact speech, such as Parkinson’s Disease.

About Aural Analytics, Inc.

Aural Analytics is the industry’s leading speech neuroscience company working with leaders in clinical research and the healthcare setting. Spun out from Arizona State University in 2015, the venture-backed company provides an easy to use Speech Vitals product platform that leverages structured speech elicitations to measure validated objective disease relevant information directly from patients in remote and clinical settings. For more information, please visit auralanalytics.com or follow Aural Analytics on Twitter, LinkedIn, and Facebook.