FDA Clears Scopio Labs’ Full Field Peripheral Blood Smear System

The FDA has granted clearance to Scopio Labs’ X100 Full Field Peripheral Blood Smear (Full Field PBS) application for use with in vitro hematology diagnosis.

Using computational imaging and artificial intelligence, the Full Field PBS application captures digital scans with a full field view of the smear, including the monolayer and feathered edge. The digital microscopy system also includes a three-slide tray and a decision support system for pre-classification of white blood cells into 16 classes, red blood cell morphology evaluations, platelet location, and pre-estimate.

“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 of Clinical Services, Pathology, and Laboratory Medicine at the University of Pennsylvania’s Perelman 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.”

Full Field PBS was also granted CE mark certification in Europe earlier this year, indicating that it meets EU safety and health protection requirements.

Source: Scopio Labs press release, October 21, 2020.