Vocalis Health's COVID-19 Screening Tool Successfully Approved in Large Clinical Study

Vocalis Health's COVID-19 Screening Tool Successfully Approved in Large Clinical Study

Besides the results of this study, Vocalis Health declared that its COVID-19 screening tool, VocalisCheck, has obtained a CE mark. VocalisCheck is the first device with CE mark approval for its medical intended utilization of screening for COVID-19.

Fremont, CA: Vocalis Health, a company pioneering AI-based vocal biomarkers in healthcare, has declared results of a clinical study conducted in collaboration with the Municipal Corporation of Greater Mumbai (MCGM) at their NESCO COVID-19 Center to validate Vocalis Health's COVID-19 screening tool, VocalisCheck.

The study incorporated more than 2,000 participants who spoke numerous languages, including English, Marathi, Hindi, and Gujarati. Results from an unblinded validation set of 288 participants showed an AUC of 0.88, which translated to the sensitivity of 80.3 percent, accuracy of 81.2 percent, and specificity of 81.4 percent.

Besides the results of this study, Vocalis Health declared that its COVID-19 screening tool, VocalisCheck, has secured a CE mark. VocalisCheck is the first device with CE mark approval for its medical intended utilization of screening for COVID-19.

"PCR testing is being used to screen for COVID-19, which is an extremely expensive, resource-intensive and time-consuming approach," stated Dr. Shady Hassan, Co-Founder, Chief Operating and Medical Officer of Vocalis Health. "Instead of misusing PCR testing for screening, utilizing a highly scalable screening tool like VocalisCheck can fill a significant gap in the current approach to COVID screening, with the ability to effectively funnel those with high risk of infection to the appropriate diagnostic test."

VocalisCheck has now proven its trustworthiness to effectively find out COVID-19 risk in multiple studies, including this study in India, providing reliable risk assessment for COVID-19 infection even in people who are not symptomatic. In the study in India, a symptom checker alone correctly found approximately 66 percent of the people with COVID-19 infection, while Vocalis Health's COVID-19 vocal biomarker achieved less than 80 percent accuracy in evaluating a person's risk of COVID-19 infection.

"We are encouraged by the study's findings, which further validate VocalisCheck's ability to screen for COVID-19," stated Tal Wenderow, CEO of Vocalis Health. "These new results, combined with our recent CE-mark approval, demonstrate our commercial readiness to deploy the VocalisCheck screening tool to help businesses, governments, universities and others safely return to work, school, healthcare and leisure while lightening the burden on health systems."