Scopio Labs Gains FDA Clearance for Its Hematology Analysis Device

Israel-based Scopio Labs has received the FDA’s 510(k) clearance for its X100HT hematology analysis device with an artificial intelligence-based peripheral blood smear (PBS) application.

The high-throughput device can hold 30 slides and process up to 40 samples an hour, delivering high-resolution digital images.

The PBS review provides information about a variety of disorders such as blood-related cancers, anemia, infections and allergies. The digital analysis eliminates the need for additional manual microscopic examination, the company said.

Scipio Labs develops AI-powered diagnostic platforms for earlier and more accurate detection of cancers, infections and other diseases. This is the company’s second FDA clearance.