VocalisCheck obtains CE mark (European Union) approval for medical use as a COVID-19 screening tool
Vocalis Health, a company pioneering AI-based vocal biomarkers in healthcare, today announced 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 included over 2,000 participants who spoke numerous languages including English, Hindi, Marathi and Gujarati. Results from an unblinded validation set of 288 participants demonstrated an AUC of 0.88, which translated to accuracy of 81.2 percent, sensitivity of 80.3 percent and specificity of 81.4 percent.
In addition to the results of this study, Vocalis Health today announced 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 use 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,” said 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 reliability to 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 in India, a symptom checker alone correctly identified approximately 66 percent of the people with COVID-19 infection, while Vocalis Health’s COVID-19 vocal biomarker achieved >80 percent accuracy in assessing 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,” explained 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.”