Vocalis Health COVID-19 Screening Tool Is Successfully Validated in Large Clinical Study

CathWorks FFRangio™ System Receives National Reimbursement Approval in Japan

CathWorks announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the application to provide reimbursement for the CathWorks FFRangio™ System,...

Levine Leichtman Capital Partners Sells FlexXray

Levine Leichtman Capital Partners ("LLCP"), a Los Angeles-based private equity firm, announced today that it has sold its portfolio company FlexXray Holdings, LLC ("FlexXray" or...

February 17, 2021

Vocalis Health notes 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 a 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.”

 

spot_img

DON'T MISS

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.