X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
by Scopio Labs
· Based in Israel →
— See more. Do more. Diagnose faster. Transforming cell morphology analysis.
Contact vendor for pricing
Regulatory Status Disclosed
Overview
The Scopio Labs X100/X100HT with Full-Field Peripheral Blood Smear (FF-PBS) Application is an end-to-end digital cell morphology solution designed to replace the traditional manual microscope. It leverages breakthrough computational photography and an AI-powered Decision Support System (DSS) to provide comprehensive analysis of peripheral blood smears. The system offers a full-field digital view of the sample, including the monolayer and feathered edge, at 100X magnification, eliminating the need to revert to manual microscopy. This technology empowers laboratory professionals to conduct WBC differentials, RBC morphology evaluation, and platelet estimations more efficiently, significantly reducing turnaround time for sample reviews. It also enables remote review, collaboration, and consultation through a secure hospital network, enhancing workflow optimization and operational efficiencies across the continuum of care.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Full-Field Digital Imaging at 100X magnification, including monolayer and feathered edge
- AI-powered Decision Support System (DSS) for cell analysis
- End-to-end digital workflow for Peripheral Blood Smear (PBS) analysis
- Remote connectivity and browser-based review capabilities through secure hospital networks
- Automated WBC detection, pre-classification into 14 classes, and quantification
- RBC morphology evaluation with AI-driven analysis and grading for 23 distinct parameters
- Automated platelet location, pre-estimation, and clump detection
- Adaptive Monolayer Detection supporting various smear types
- Reduced turnaround time for sample reviews by up to 60%
- Standardized digital reporting with images, annotations, and flagged abnormalities
Use Cases
- Routine peripheral blood smear review in hematology laboratories
- Diagnosis and monitoring of hematological disorders, including blood cancers, anemia, infections, and allergies
- Remote consultation and collaboration among hematopathologists and lab professionals
- Optimization of laboratory workflows and operational efficiencies
- Educational tool for medical students, residents, and fellows in hematology
- Research in digital cell morphology and hematopathology
What Physicians Need to Know
LIS/LIMS Integration
The X100/X100HT system generates digital reports that can integrate directly into Laboratory Information Systems (LIS). The browser-based application allows access from any workstation within the secure medical facility network or securely connected remotely.
Supported Assay Types
Primarily supports Full-Field Peripheral Blood Smear (PBS) analysis, including White Blood Cell (WBC) differentials with pre-classification into 14 classes, Red Blood Cell (RBC) morphology evaluation with pre-grading of 22 parameters across over 10,000 cells, and automated platelet estimations, including identification of platelet clumps. It also identifies pathological elements such as blasts, immature myeloid cells, and nucleated red blood cells (NRBCs).
QC/QA Features
Features an AI-powered Decision Support System (DSS) that provides reliable and consistent information, enhancing conventional analysis methods. The system offers AI-driven analysis and grading for numerous cell parameters, while maintaining essential human expert oversight for final diagnostic decisions. Studies have shown high accuracy for WBC (96.29% efficiency), RBC morphology (99.77% agreement), and platelet estimation (94.89% efficiency), with successful reproducibility and repeatability.
Result Interpretation AI
Utilizes an AI-powered Decision Support System (DSS) for detection, pre-classification, and quantification of blood cells. It pre-classifies WBCs into 14 categories and provides AI-driven analysis and grading for 23 distinct RBC morphology parameters and platelet clumps. The AI assists in improving diagnostic efficiency, objectivity, and accuracy, acting as a decision support system that requires operator review and approval/correction.
Critical Value Alerts
While not explicitly termed 'critical value alerts,' the AI-powered DSS is designed to identify abnormal cells, including blasts, immature myeloid cells, and NRBCs, which are crucial for rapid diagnosis and expediting patient access to life-saving treatments. The system highlights deviations from normal ranges, enabling timely expert intervention.
Instrument Interfaces
The X100 and X100HT platforms are digital imaging systems. The X100HT can connect with automated hematology workcells like the Beckman Coulter DxH 900 and DxH Slidemaker Stainer II for continuous loading, scanning, and analysis. It supports all Romanowsky stains and various barcode types (Data matrix Code 128, Code 39, EAN-8, EAN-13, QR Code), also accommodating slides without barcodes. The X100 has a 3-slide tray with a throughput of up to 15 slides/hour, while the X100HT has a 30-slide capacity (3 cassettes x 10 slides) with a throughput of up to 40 slides/hour for 200 WBC differentials.
Reference Range Intelligence
The AI system's ability to pre-classify cells, grade RBC morphology parameters, and identify abnormal cell features effectively highlights deviations from established normal ranges. This intelligence supports laboratory professionals in assessing whether cell counts or morphologies fall outside expected parameters, guiding their diagnostic review.
Turnaround Time Impact
The system significantly reduces Peripheral Blood Smear (PBS) review turnaround times (TAT), with studies showing reductions of 41.4% on the first weekend day, 33.1% on the second, and eliminating backlogs to reduce TAT by 59.1% on the first weekday. Overall morphology TAT can drop by 15.8%, and the median time for PBS review can be reduced by 60% compared to manual methods. Remote review capabilities contribute to these efficiencies by allowing off-site analysis.
Physician Tip
Leverage the Scopio X100/X100HT for rapid, high-resolution digital peripheral blood smear analysis, enabling remote review and collaboration with specialists. The AI-powered decision support system can enhance diagnostic consistency and efficiency, particularly for complex cases, by providing pre-classification and detailed morphological grading. Remember that while AI offers valuable insights, the final diagnostic decision remains with the trained professional. The reduced turnaround time can lead to faster clinical decisions and potentially earlier initiation of critical treatments.
The Scopio X100/X100HT is designed for seamless integration with existing Laboratory Information Systems (LIS) for automated report documentation. Its browser-based access facilitates remote connectivity within secure hospital networks. For high-throughput laboratories, the X100HT can be integrated with automated hematology workcells, such as those from Beckman Coulter, to create a more streamlined and efficient end-to-end workflow for slide processing, scanning, and analysis.
Details
| Category | Lab & Diagnostics, Pathology AI |
| Pricing | Contact vendor for pricing — Contact vendor for pricing |
| Deployment | On-premise (scanner) with browser-based access via secure hospital network |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The Scopio X100 and X100HT platforms with the Full-Field Peripheral Blood Smear (PBS) Application are FDA-cleared and CE-marked. Scopio Labs has received multiple FDA clearances, including a recent one (K243144) for enhanced Decision Support System (DSS) features for AI-powered red blood cell morphology analysis and platelet clump detection. |
| Integrations | |
| EHR | Not specified |
| Specialties | Hematology, Laboratory Medicine, Pathology |
Ratings & Reviews
No reviews yet. Be the first to review this tool!
Rate X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
Press & Coverage
PR Newswire
Scopio Labs Receives Fourth FDA Clearance, Elevating Digital Morphology with Enhanced AI-Powered RBC and Platelet Capabilities
Scopio Labs announced its fourth FDA clearance for new Decision Support System features on its X100 and X100HT platforms with the Peripheral Blood Smear (PBS) Application, enhancing AI-powered analysis of red blood cell morphology and platelet clumps.
2025-07
Clinical Lab Products
Scopio Labs Receives FDA Clearance for Decision Support System on X100 and X100HT Platforms
Scopio Labs secured its fourth FDA clearance for enhanced decision support features on its X100 and X100HT platforms, improving AI-powered red blood cell morphology analysis and platelet clump detection in peripheral blood smears.
2025-07
PubMed (International Journal of Laboratory Hematology)
Performance Evaluation of the Scopio Labs X100HT Digital Morphology Analyzer and Abnormal Cell Detection in Peripheral Blood Smears
A study published in the International Journal of Laboratory Hematology found that the Scopio Labs X100HT Full Field PBS system reliably performs WBC differential analysis and identifies abnormal cells, with expert post-classification enhancing diagnostic accuracy.
2025-09
Scopio Labs Press Release
Scopio Labs Unveils First-of-Its-Kind AI-Powered Solution to Fully Automate Blood Morphology
Scopio Labs introduced its Complete Blood Morphology (CBMu00ae) analyzer, an AI-powered solution designed to automate blood morphology analysis and reporting, aiming to bring unprecedented scale, efficiency, and standardization to hematology.
2025-07
Scopio Labs Press Release
Scopio Labs Receives Groundbreaking FDA Clearance for First-Ever Digital Bone Marrow Aspirate Application
Scopio Labs received De Novo FDA clearance for its Full-Field Bone Marrow Aspirate (FF-BMA) Application, establishing a new regulatory category for all-digital bone marrow aspirate analysis software and integrating with its X100 and X100HT platforms.
2024-04
MedTech Dive
Scopio Labs wins de novo nod for bone marrow analysis software | MedTech Dive
Scopio Labs received de novo authorization from the FDA for its bone marrow analysis software, allowing its X100 and X100HT devices to image and present cells in bone marrow smears digitally.
2024-04
Beckman Coulter Press Release
Beckman Coulter and Scopio Labs Add World's First Digital Bone Marrow Imaging and Analysis to Long-Term Partnership
Beckman Coulter and Scopio Labs expanded their partnership to include a global distribution agreement for Scopio's Full-Field Bone Marrow Aspirate (FF-BMA) Application, which is CE-Marked for use with the X100/X100HT platforms.
2024-09
Scopio Labs Press Release
Study Reveals Faster Turnaround Time in Clinical Laboratory With Scopio Labs' Remote Digital Morphology
A study published in Applied Clinical Informatics, conducted by Tel Aviv Sourasky Medical Center, demonstrated that Scopio's X100 with Full-Field PBS Application significantly reduces laboratory turnaround time for peripheral blood smear review.
2023-04
Videos
Product demos, reviews, and walkthroughs for X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application.
Future of Digital Cell Morphology is Now 100X Closer
Beckman Coulter Dx
Frequently Asked Questions
The X100/X100HT with its Full Field PBS Application is designed as an end-to-end digital solution that can replace manual microscopy for peripheral blood smear review. It integrates by digitizing the entire smear, providing AI-powered pre-classification and analysis, which can significantly reduce turnaround time for sample reviews by up to 60%.
The X100 and X100HT with the Full Field Peripheral Blood Smear Application have received FDA clearance and CE mark certification for in vitro hematology diagnosis. Regarding data privacy, while specific HIPAA compliance details would need to be confirmed with the vendor, medical AI systems are generally designed to adhere to stringent data security protocols and patient confidentiality regulations.
The AI in the X100/X100HT aims to provide consistent and objective analysis, which can help reduce inter-observer variability inherent in manual review. Developers of AI in healthcare are increasingly focused on ethical considerations, including ensuring data diversity and representativeness in training sets to mitigate bias and promote equitable outcomes across diverse patient populations.
The X100/X100HT's AI-powered system offers high accuracy in classifying various cell types and detecting abnormalities, often enhancing efficiency and standardization compared to traditional manual microscopy, which can be time-consuming and subjective. While AI can pre-classify and provide decision support, human oversight by a hematopathologist remains crucial, especially for complex or ambiguous cases.
The cost of high-end, fully automated hematology analyzers with advanced features like AI can range from $50,000 to over $150,000, with additional costs for consumables, service, and training. The projected ROI stems from significant reductions in turnaround time, improved workflow efficiencies, and enhanced diagnostic consistency, potentially leading to better patient care and optimized resource utilization.
While AI systems are highly capable, limitations can exist in detecting extremely rare cell types or very subtle morphological changes, especially if these are underrepresented in the AI's training data. Cases with very low cell counts or significant pre-analytical variability might also present challenges, often requiring expert human review for definitive diagnosis.
The X100/X100HT functions as an AI-powered Decision Support System, meaning it provides pre-classifications and analyses to assist lab professionals. For ambiguous or critical cases, the system is designed to facilitate pathologist review and override, allowing experts to verify, reclassify, or flag abnormalities within the digital interface, ensuring human expertise remains central to the diagnostic process.
Suggest an Edit →
| Last Verified: 2026-04-19 | First Added: 2026-04-19
Investors who backed X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
Funded through the company that built this tool.
