Newsight Imaging, an Israeli startup developing imaging solutions and chips for spectral and machine vision applications, announced today that the company’s SpectraLIT™ device, powered by Virusight Diagnostic’s AI software, which enables a ground-breaking 20-second COVID-19 diagnosis, has received the Conformité Européene (CE-European Conformity) Mark approval. The CE marking confirms that SpectraLIT™ meets the requirements of the European Medical Devices Directive, which will allow Newsight to commercialise the device with its operating system across the European Union and other CE Mark geographies.
The SpectraLIT™ device is a miniature spectrometer with advanced capabilities, operated by AI classification algorithms and developed by Virusight Diagnostic, Newsight’s joint venture with Sheba Medical Center’s ARC Innovation Center, one of the Top 10 Hospitals in the World according to Newsweek magazine. The testing procedure is easy to operate, with immediate results for symptomatic and asymptomatic patients. The AI software was successfully clinically tested at a medical institute in the USA. 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.
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Eli Assoolin, CEO of Newsight Imaging and Virusight Diagnostic Chairman, said, “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. 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.”
Prof. Eyal Zimlichman, Chief Medical and Innovation Officer at Sheba Medical Center and board member at Virusight, added: “The CE approval marks another step in the commercialization of the Virusight COVID-19 quick diagnostic kit. With the realisation 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.”