Tel Aviv-Based Scopio Labs Wins New FDA Approval for AI Blood Testing Tool

This marks the company’s fourth FDA clearance and brings advanced artificial intelligence tools to hospitals and labs across the United States.

By Shula Rosen

Scopio Labs, a Tel Aviv medical technology company, has received approval from the U.S. Food and Drug Administration (FDA) for new features in its digital blood testing system.

This marks the company’s fourth FDA clearance and brings advanced artificial intelligence tools to hospitals and labs across the United States.

The upgraded system helps doctors and lab technicians analyze blood samples more quickly and accurately.

Using AI, it can scan thousands of cells at once, spotting changes in red blood cells and identifying platelet clumps—important clues for diagnosing conditions like anemia, clotting disorders, and other blood-related diseases.

Traditionally, lab staff have had to examine blood smears under a microscope, a process that can be time-consuming and inconsistent.

Scopio’s digital system creates full images of the samples on a screen and highlights key details for review.

The goal is to save time, improve accuracy, and give doctors clearer information, while still leaving the final judgment in the hands of trained specialists.

“These enhancements bring added consistency and efficiency,” said Scopio CEO Itai Hayut told Our Crowd. “With this clearance, we can now provide U.S. hematology labs with decision support tools that fit smoothly into their daily work.”

The company says the new FDA approval allows its technology to be used more widely in the U.S., where demand is growing for faster and more reliable testing.

By combining digital imaging with AI analysis, Scopio Labs hopes to speed up diagnoses and improve patient care.

This clearance strengthens Scopio’s place in the global shift toward digital pathology, where advanced technology is changing how doctors and labs handle routine medical testing.