FDA Acknowledges Speech's Role in ALS Treatment
The U.S. Food and Drug Administration has granted Aural Analytics' Speech Vitals-ALS designation as a Breakthrough Device. Speech Vitals - ALS is used in the collection and analysis of speech recordings to assist neurologists in monitoring 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.
"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 and regulatory affairs at Aural Analytics, in a statement. "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.
Once Speech Vitals achieves regulatory clearance, the technology will be applied to additional conditions that impact speech, such as Parkinson's Disease.