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

This is the company's second FDA clearance, broadening its suite of fully digital platforms to cater to all lab sizes and networks. Coupling high throughput capabilities with the highest resolution for hematological analysis, the X100HT caters to major medical facilities and labs across the world.
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Scopio Labs Awarded FDA Clearance for High Throughput Hematology Digital Cell Morphology Platform, Replacing Microscopes with Digitization

TEL AVIV, Israel, June 9, 2022 /PRNewswire/ — Scopio Labs, a medtech company that develops AI-powered diagnostic platforms for earlier and more accurate detection of cancers, infections, and other diseases, announced today 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.

Scopio’s suite of digital Full-Field™ imaging and AI-powered Decision Support platforms. The X100 (left) and the X100HT (right) cater to hospitals and lab networks of all sizes, offering fully remote review capabilities for real-time diagnosis and improved clinical decision making.

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.

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.”

As affirmed by the American Society for Clinical Laboratory Science, there is a critical shortage of medical laboratory professionals. Aiming to overcome these barriers, Scopio delivers end to end digital transformation of the lab process for Full-Field™ PBS review of white blood cells, red blood cells, and platelet estimation. The results of every assessment (including images, annotations and flagged abnormalities) are automatically documented in a standardized digital report and seamlessly shared across the continuum of care.

As the first Full-Field™ digital imaging and AI-powered analysis platform, Scopio provides a solution to the laboratory workforce shortage by reaching a level of workflow efficiency and traceability that has never been possible before.

About Scopio Labs

Scopio Labs, founded in 2015, develops breakthroughs in digital microscopy that help improve accuracy, efficiency and accessibility wherever the microscope plays a role in the diagnostic process. The Scopio microscope captures and digitizes full slide microscopy data. Using advanced computational photography techniques to reconstruct data, Scopio offers an automated digital microscopy scanning system with uniquely high resolution and quality images.

The company creates end-to-end solutions that provide AI-based decision support systems and remote collaboration tools in hematology, pathology, research and veterinary medicine. Scopio supports clinical applications while also powering innovation in areas such as academic research and drug discovery.

For more information visit our website, http://scopiolabs.com and follow the company on LinkedIn and Twitter.

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