Scopio Labs Awarded FDA Clearance for High Throughput Hematology Digital Cell Morphology Platform, Replacing Microscopes with Digitization

Scopio Labs, a medtech company that develops AI-powered diagnostic platforms for earlier and more accurate detection of cancers, infections, and other diseases, announced that its ground-breaking X100HT device with Peripheral Blood Smear (PBS) Application has received U.S. FDA 510(k) clearance. Coupling high throughput capabilities with the highest resolution for hematological analysis, the X100HT caters to major medical facilities and labs across the world.

With the increasing worldwide prevalence of hematological disorders and malignancies, the accuracy and timeliness of PBS results are critically important for early diagnosis and effective treatment initiation. The peripheral blood smear review is a powerful diagnostic tool that provides rapid, reliable access to information about a variety of disorders such as blood related cancers, anemia, infections, and allergies. The majority of these tests are performed manually, but Scopio’s disruptive Full-Field PBS morphology solution completely eliminates the need for additional manual microscopic examination.

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In manual microscopy, users must choose between a large field of view or high resolution. Scopio’s devices eliminate that tradeoff completely, capturing large scan areas at 100X magnification. Holding 30 slides and processing up to 40 samples an hour, Scopio’s X100HT can meet the high throughput requirements of large hospitals and labs, while fully supporting remote review capabilities, enabling a new subfield of telehematology. Hospital and lab networks can now operate seamlessly across multiple facilities of all sizes, with workload balancing, remote consultations, addressing personnel shortages and more.

“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,” said Erez Naaman, CTO and Co-Founder of Scopio Labs. “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.”

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