Artificial intelligence (AI) health tech company Vocalis Health has obtained CE mark (EU) approval for its VocalisCheck for medical use as a screening tool for Covid-19.

A software-only product, VocalisCheck can be accessed using smartphones or other devices. The voice recording of users will be transformed into a picture (spectrogram) with 512 features when they simply count from 50 to 70.

Based on the voice recordings of Covid-19-positive subjects in clinical trials, the picture is compared using AI machine learning / deep learning techniques to a composite picture to decide whether there is a high or low association between them.

The technology can be integrated into existing mobile or web applications or can be accessed through a web-based portal.

Vocalis Health noted that VocalisCheck is not a diagnostic tool but is made to be used as a screening tool for offering a reliable risk score to support people who may need additional diagnostic testing.

It can help health systems to allocate diagnostic resources in an efficient manner.

The company has also reported results from a clinical study carried out in partnership with India’s Municipal Corporation of Greater Mumbai (MCGM) at its NESCO COVID-19 Centre to validate VocalisCheck.

The study had more than 2,000 subjects. Results from an unblinded validation set of 288 subjects showed an AUC of 0.88, which translated to 81.2% accuracy, 80.3% sensitivity, and 81.4% specificity.

Vocalis Health co-founder, chief operating, and medical officer Dr Shady Hassan said: “PCR testing is being used to screen for Covid-19, which is an extremely expensive, resource-intensive, and time-consuming approach.

“Instead of misusing PCR testing for screening, utilising a highly scalable screening tool like VocalisCheck can fill a significant gap in the current approach to Covid-19 screening, with the ability to effectively funnel those with high risk of infection to the appropriate diagnostic test.”

VocalisCheck is proven to be reliable in detecting Covid-19 risk in multiple studies, including in India.