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Scopio Labs obtains FDA approval for blood smear

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Israeli digital microscopy company Scopio Labs announced this week that it has received US FDA 510 (k) approval for an X100HT device with a full-field peripheral blood smear (PBS) application to improve the accuracy and speed of blood tests. did.

As blood disorders such as blood-related cancers, anemias, infections and allergies become more prevalent around the world, review of peripheral blood smear is becoming a very important diagnostic tool for accurate analysis. Most of these tests are done on most casts that are performed manually, but the Scopios full-field PBS morphology solution completely eliminates the need for additional manual microscopy.

Scopios devices can capture large scan areas at 100x magnification, in contrast to traditional manual microscopes, which cannot provide high resolution and a wide field of view at the same time. The X100HT holds 30 slides and can process up to 40 samples per hour, making it ideal for meeting high throughput requirements in large hospitals and laboratories.

Founded in 2015 by Itai Hayut and Erez Naaman, the Scopio Labs platform uses state-of-the-art computational photographic technology to automate the imaging of complete microscope samples into a unique high-resolution digital scan. The company has also built and integrated a variety of AI and remote consulting solutions for large and small laboratories and hospitals to improve the diagnostic process and reduce travel time. To date, the company has raised $ 73 million from investors such as OurCrowd, Aurum Ventures and Ilex Medical.

Erez Naaman, CTO and co-founder of Scopio Labs, has expanded its suite of fully digitized AI-powered diagnostic platforms to accelerate PBS analysis, improve results consistency, and reduce review times. I’m excited about what I can do. At Scopio, we are determined to usher in a digital revolution in laboratory medicine. Our devices provide fully remote capabilities for real-time diagnostic and treatment decisions, enabling professionals to review, collaborate and consult anytime, anywhere using AI-powered applications.

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