Israeli startup Scopio Labs, which developed an AI-powered digital microscopy system, announced that it has received FDA clearance to market its X100 product with Full Field Peripheral Blood Smear (Full Field PBS) Application, unlocking the potential of in vitro hematology diagnosis

Tapping the blood stream for health data

After earlier this year Scopio unlocked the European market, by attaining the CE mark of approval, now the Israeli startup is aiming to cross the pond with the coveted FDA OK. Using advanced computational photography imaging and tailored AI tools, Full Field PBS gives clinical laboratories an unprecedented ability to capture digital scans with full field view of the monolayer and feathered edge at 100X oil immersion resolution level. This gives physicians a potentially very helpful tool in the early diagnostics game, by tapping into the health info we have in our blood. Due to technicians reverting to manual microscopes because of archaic imaging visuals, Scopio provides a system that could be a viable solution for the 120,000 laboratories that conduct PBS testing.

"Understanding the challenges lab technicians, hematologists and hematopathologists face when evaluating blood samples containing large numbers of morphologically-unique cells in a timely fashion, we designed our solution specifically for hematology labs where we can improve quality of care, consistency of results and reduce review time," said Scopio Labs' CEO and Co-Founder, Itai Hayut. "We are thrilled to receive FDA clearance following the successful completion of a multi-center study, as we bring our innovative solution to laboratories around the U.S. to help improve the outcome of diagnosis and care."

By Scopio implementing its fully digital, automated scan and image acquisition system, the Full Field PBS offers unique user experience of in-slide navigation to specified locations within a slide, all through a modern web browser interface. Click here to experience the Scopio Full Field PBS scan.

"The field of microscopy is poised for transformation, and I am enthusiastic about the prospects of Scopio Labs' innovative application," said Michael D. Feldman, MD, PhD, Vice Chairman Clinical Services, Pathology and Laboratory Medicine at University of Pennsylvania School of Medicine. "With new digital technologies combining imaging and artificial intelligence being introduced into the laboratory, we can provide clinicians with tools that strengthen their capabilities."

"With the first clinical-level solution that digitizes large portions of PBS, Scopio Labs is taking hematology through the next technological revolution with exponential impact to the industry, leveraging its unique computational imaging technology and specifically designed computer vision tools," said Erez Na'aman, co-founder and CTO of Scopio Labs. "We are transforming hematology diagnostics, empowering experts and propelling the field forward."

Earlier this year, Scopio closed a $16 million Series B funding round, bringing total funding to date to $30 million. The company was co-founded by CEO Itai Hayut and CTO Erez Na’aman in 2015, and has offices in both Tel Aviv and the “Garden State” - New Jersey.