Company Spotlight: Scopio X100 - Automating the Blood Smear for Hematology

We unpack the FDA 510(k) summary for Scopio Labs' X100 and X100HT systems with their modified Full Field Peripheral Blood Smear Application. The document details how the device uses artificial neural networks to digitally locate and pre-classify blood cells, adding new decision support tools for red blood cells and platelets while keeping the human technologist firmly in control.

Key points

• The FDA cleared the Scopio X100 and X100HT as Class II automated cell-locating devices on June 27, 2025.
• The system captures multiple images to reconstruct a 100X magnification view of peripheral blood smears without using immersion oil.
• A newly added Decision Support System suggests red blood cell morphology grades and platelet clumps using a dotted line on the screen.
• In a 1200-slide method comparison study, overall agreement for red blood cell color was 97.88%, while platelet clumping agreement was 87.08%.
• The FDA requires the human technologist to manually review the images and actively mark the final grading, meaning the system is an assistant, not an autonomous diagnostic tool.

Source: FDA 510(k) summary K243144: X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (Scopio Labs) - U.S. Food and Drug Administration, 2025

This episode is an AI-generated conversation summarising a public document; the hosts' voices are synthetic. It is for information only and is not medical advice. Always refer to the original source.

Company: Scopio Labs (scopiolabs.com) · Product: X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application · FDA 510(k) K243144

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/company-spotlight-scopio-x100-automating-the-blood-smear-for-hematolog-5c150f