AI healthcare company Vocalis Health stated on Wednesday that its COVID-19 VocalisCheck screening tool has received the CE mark approval for its medical intended use for the screening for COVID-19.

The company provided the results of a clinical study conducted in partnership with the Municipal Corporation of Greater Mumbai at NESCO COVID-19 Centre to validate VocalisCheck. The study included 2,000 participants who spoke numerous Indian languages. Results from 288 participants demonstrated an AUC of 0.88, which translated to accuracy of 81.2%, sensitivity of 80.3% and specificity of 81.4%.

According to the company, VocalisCheck can effectively identify COVID-19 risk in multiple studies, including this study in India, delivering reliable risk assessment for COVID-19 infection even in people who are not symptomatic.

In the study conducted in India, a symptom checker correctly identified approximately 66% of the people with COVID-19 infection, while Vocalis Health's COVID-19 vocal biomarker achieved >80% accuracy in assessing a person's risk of COVID-19 infection, said the company.

VocalisCheck is a software-only product that can be accessed via smartphones or other devices, concluded the company.