AI Software-Powered Device That Enables Ground-Breaking 20-Second COVID-19 Diagnosis Secures CE Mark Approval

An AI software-powered device that enables a ground-breaking 20-second COVID-19 diagnosis, has received the Conformité Européene (CE-European Conformity) Mark approval.

Newsight Imaging Ltd. (Ness Ziona, Israel) has received CE marking for its SpectraLIT device, powered by Virusight Diagnostic Ltd.’s (Ramat Gan, Israel) AI software. The SpectraLIT device is a miniature spectrometer with advanced capabilities, operated by AI classification algorithms and developed by Virusight, Newsight’s joint venture with Sheba Medical Center’s ARC Innovation Center (Tel HaShomer, Israel). The testing procedure is easy to operate, with immediate results for symptomatic and asymptomatic patients. The AI software was successfully clinically tested by a US medical institute. Currently, the solution could be used in labs with trained operators, and the testing is done using nasopharyngeal swabs tests. However, the company intends to offer this solution for any point-of-care or even for at-home testing.

“We are very excited to achieve this important milestone for our SpectraLIT Solution, which, with Virusight’s AI, is actually a diagnosis platform for many potential cases of pathogen diagnosis, able to change the way the world deals with pandemics,” said Eli Assoolin, CEO of Newsight Imaging and Virusight Diagnostic Chairman. “We are engaged in an intensive effort to achieve more worldwide regulation approvals and to re-validate our solution in over 36 pilot programs around the globe, on all 5 continents. We are looking forward to expanding the system capabilities to diagnose other pathogens while running full commercial deployment with carefully selected partners.”

“The CE approval marks another step in the commercialization of the Virusight COVID-19 quick diagnostic kit,” added Prof. Eyal Zimlichman, Chief Medical and Innovation Officer at Sheba Medical Center and board member at Virusight. “With the realization that with the global roll out of vaccination efforts, COVID-19 will become a new reality that will require agile diagnostic solutions, this represents an important milestone. We will continuously work with our partner, Newsight, to bring about such solutions. Sheba Medical Center and ARC, our global innovation program, will continue to push the limits of innovation and impact the future of health.”

Related Links:
Virusight Diagnostic Ltd.
Newsight Imaging Ltd.
Sheba Medical Center