The U.S. Food and Drug Administration (FDA) has granted software developed by Aural Analytics as a breakthrough device. The designation will provide the technology, called Speech Vitals – ALS, with priority review to help patients living with amyotrophic lateral sclerosis (ALS).
Aural Analytics, a speech neuroscience company based in Arizona, US, say that the breakthrough device designation intended for neurological disorders is fewer than 140 – even fewer are for ALS treatment.
“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.
The technology is a software application that collects and analyses speech recordings to assist neurologists in monitoring patients with ALS in clinical settings and home environments.
In the US, someone is diagnosed with ALS every 90 minutes, according to the ALS Association. In the same timeframe, a patient dies from the condition.
Aural Analytics, who were awarded a $1.4m grant from the National Institutes of Health in 2022, also intends to apply Speech Vitals to additional conditions that affect speech such as Parkinson’s Disease.
Samples of speech collected by Speech Vitals from app-based tasks can help monitor speech as a vital sign – which is often not as digitally advanced as other parameters in monitoring. Metrics of speaking rate, articulatory precision, and phonatory duration are measured over a few minutes of speech and can provide neurologists with easy-to-access information and reduce patient burden.
The technology is also SDK-ready, with implementation into various healthcare system applications ready once Speech Vitals received regulatory clearance.
In 2022, the speech analytics company partnered with Medidata to deploy the technology on the latter’s Sensor Cloud Network – leveraging the utility of speech in clinical research.