AI-powered scope developer says new FDA clearance opens the door for telehematology

The Scopio X100 (left) and new X100HT [Image courtesy of Scopio Labs]Scopio Labs today announced FDA 510(k) clearance for its X100HT, which features a new slide loader that automatically prepares samples and feeds them into the digital blood scanner for AI-powered analysis.

The Tel Aviv-based digital microscope developer said the technology eliminates the need for manual microscopic examination when reviewing white and red blood cells and estimating platelet counts.

Based on the X100 that was 510(k)-cleared by the FDA in 2020, the X100HT has a slide loader with three cassettes that can each hold 10 slides. After the slides are placed in the cassettes and inserted into the slide loader, the slide loader automatically applies mounting media and a glass cover slip onto the slides and sequentially inserts them into the scanner for processing, according to the FDA’s decision summary.

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