We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
INTEGRA BIOSCIENCES AG

Download Mobile App





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

By LabMedica International staff writers
Posted on 01 Apr 2021
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. More...
(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



Platinum Member
Fully Automatic ACLIA Analyzer
MAGLUMI X8
Gold Member
SARS‑CoV‑2/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)
New
Nucleic Acid Purification Instrument
QIAsymphony Connect
Gold Member
Platelet Function Analyzer
PL-12
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Clinical Chemistry

view channel
Image: Lead author Professor Chamindie Punyadeera. (Image Credit: Griffith University)

Breath Analysis Shows Promise for Distinguishing Cancerous from Benign Lung Nodules

Lung nodules are frequently detected during imaging, but distinguishing malignant from benign findings can require invasive procedures. Some patients undergo biopsies, bronchoscopy, or surgery before learning... Read more

Molecular Diagnostics

view channel
Image: Skin samples from people with a suspected genetic myopathy were examined for confirmation of disease. Brown spots show abnormal protein buildup inside the nuclei of cells (purple), typical of a type of myopathy called oculopharyngodistal myopathy. (Image Credit: Garvan Institute)

Long-Read Sequencing Test Identifies Genetic Causes in Inherited Muscle Disease

Inherited muscle diseases are highly heterogeneous and often progressive, leaving many patients without a molecular diagnosis despite extensive testing. Conventional assays typically target individual... Read more

Immunology

view channel
Image: Aptiva utilizes particle-based multi-analyte technology (PMAT) (Photo courtesy of Werfen)

Werfen Expands Automated APS Testing with FDA-Cleared and CE-Marked IgA Reagent

Antiphospholipid syndrome (APS) is an autoimmune disorder associated with thrombosis and pregnancy complications, but its symptoms can overlap with those of other conditions, complicating diagnosis.... Read more

Microbiology

view channel
Image: Each PhAST instrument supports random-access processing of up to four samples simultaneously, delivering a throughput of up to 12 samples per eight-hour shift. (Photo courtesy of PhAST)

FDA Clears Rapid Phenotypic Antimicrobial Susceptibility System for Positive Blood Cultures

Bloodstream infections require prompt treatment, but antimicrobial susceptibility results often lag behind a positive blood culture. Conventional testing can take another 24 to 48 hours after a culture... Read more

Industry

view channel
Image

Collaboration Combines AI Cognitive Assessment and RNA Blood Testing for Earlier Alzheimer’s Detection

Alzheimer’s disease is often identified only after substantial neurodegeneration, partly because current diagnostic pathways are fragmented and difficult to scale. As treatment shifts toward earlier intervention,... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.