June 17, 2022—Scopio Labs received FDA 510(k) clearance for its X100HT hematology digital cell morphology platform with peripheral blood smear review.
“We’re excited to expand our suite of fully digital AI-powered diagnostic platforms to accelerate PBS analysis, improve consistency of results, and reduce review time,” Erez Naaman, CTO and cofounder of Scopio Labs, said in a press statement. “At Scopio, we are determined to usher in the digital revolution to laboratory medicine. Our devices offer complete remote capabilities for real-time diagnosis and treatment decisions, allowing experts to review, collaborate, and consult from anywhere, and at any time, using our AI-powered applications.”
The X100HT holds 30 slides and processes up to 40 samples per hour. The system also features full-field imaging at 100x resolution and supports remote review capabilities.