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

Thursday, March 30, 2023

Aural Analytics, Inc., a leading provider of clinical-grade speech analytics, has announced that its Speech Vitals - ALS technology has been designated as a Breakthrough Device by the US Food and Drug Administration (FDA). This software application aids neurologists in monitoring amyotrophic lateral sclerosis (ALS) in adults, both in clinical and home environments, by analyzing speech recordings.

The Breakthrough Device Designation is a prestigious recognition, with only a limited number of devices holding this designation, especially in the field of neurological disorders and ALS treatment. Devices with breakthrough designation are known to offer more effective treatment or diagnosis for life-threatening or debilitating conditions. The aim is to expedite the approval process, ensuring timely access to groundbreaking technologies for patients and healthcare providers.

Jeremy Moore, the Director of Quality Assurance & Regulatory Affairs at Aural Analytics, expressed his enthusiasm about achieving breakthrough designation for Speech Vitals - ALS, emphasizing the FDA's recognition of its potential to improve the management of ALS. Aural Analytics looks forward to collaborating closely with the FDA to further enhance the platform and obtain De Novo clearance, enabling physicians and patients to benefit from its capabilities.

Speech Vitals captures brief speech samples from patients through app-based tasks, measuring various speech-motor metrics such as speaking rate, articulatory precision, and phonatory duration. This approach simplifies the assessment of speech-motor conditions, reducing the burden on patients. The user-friendly app can be deployed on any device, whether in a clinical setting or at home. Speech Vitals is also SDK-ready, facilitating seamless integration into healthcare system applications, supporting clinicians in their everyday practice.

Aural Analytics has future plans to expand the indications for Speech Vitals - ALS, including its use in diagnosis. Once regulatory clearance is obtained, the technology will be applied to other speech-related conditions, such as Parkinson's Disease.


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