Scopio Labs Obtains FDA Clearance for Blood Smear Device

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Israel Society for Digital Microscopy Scopio Laboratoriesannounced this week that it has received 510(k) clearance from the US FDA for its X100HT device with Full-Field Peripheral Blood Smear (PBS) application to improve the accuracy and speed of hematology testing.

As hematological disorders As blood-related cancers, anemia, infections and allergies continue to grow worldwide, peripheral blood smear examinations have become critically important diagnostic tools for accurate analysis. Most of these tests are performed manually in most casts, however, Scopio’s Full-Field PBS Morphology Solution entirely eliminates the need for additional manual microscopic examination.

Scopio’s devices are capable of capturing large scanning areas at 100X magnification, unlike traditional handheld microscopy which is unable to simultaneously provide high resolution and wide field views. The X100HT can hold 30 slides and process up to 40 samples per hour, and is therefore well suited to meet the high throughput requirements of large hospitals and laboratories.

Founded in 2015 by Itai Hayut and Erez Na’aman, Scopio Labs’ platform automates the imaging of entire microscopy specimens into single high-resolution digital scans using state-of-the-art computational photography techniques. The company has also built and integrated various AI and remote consultation solutions for large and small laboratories and hospitals to improve diagnostic processes and reduce turnaround times. The company has raised $73 million to date from investors including OurCrowd, Aurum Ventures, and Ilex Medical, among others.

“We are excited to expand our suite of all-digital, AI-powered diagnostic platforms to accelerate PBS analysis, improve result consistency, and reduce exam time,” said Erez Naaman, CTO and co-founder of Scopio Labs. “At Scopio, we are determined to usher in the digital revolution in laboratory medicine. Our devices provide comprehensive remote capabilities for real-time diagnostic and treatment decisions, allowing experts to review, collaborate and consult from anywhere, anytime, using our powered apps by AI.

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