Startup Vocalis Health today announced that its artificial intelligence-aided screening tool, VocalisCheck, has obtained a CE mark for screening for COVID-19.

VocalisCheck is designed as a screening tool that can deliver a reliable risk score to guide people who may need diagnostic testing for the coronavirus. A smartphone or other device using the software records users counting from 50 to 70 and transforms their voice recording to a picture (spectrogram) containing 512 features. The software uses AI and deep learning techniques to compare each spectrogram to a composite picture based upon the voice recordings of COVID-19-positive clinical trial participants.

VocalisCheck is not intended to serve as a diagnostic tool, according to the Newton, Mass.-based company.

VocalisHealth also announced the results of a clinical study conducted in collaboration with the Municipal Corporation of Greater Mumbai to validate 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 accuracy of 81.2%, sensitivity of 80.3% and specificity of 81.4%.

“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,  COO and chief medical officer of Vocalis Health., in a news release. “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.”

“We are encouraged by the study’s findings, which further validate VocalisCheck’s ability to screen for COVID-19,” added company CEO Tal Wenderow. “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.”

In October 2020, Vocalis announced the start of a collaboration with Mayo Clinic to identify vocal biomarkers for pulmonary hypertension to help physicians detect and treat the condition in their patients.