miLab™ BCM
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Regulatory Status Disclosed
Overview
miLab™ BCM by Noul is an AI-powered digital microscopy system designed for blood cell morphology analysis. It is intended for use in clinical laboratories and by pathologists and hematologists.
- What it does: The system automates the process of analyzing peripheral blood smears. It captures high-resolution images of blood cells, classifies different cell types, and provides quantitative and qualitative analysis of cell morphology. This includes identifying and counting various white blood cells, red blood cells, and platelets, as well as flagging abnormal cells for further review.
- Who it is for: miLab™ BCM is primarily for hematologists, pathologists, and medical technologists working in hospital laboratories, reference laboratories, and other clinical settings that perform routine and specialized blood smear evaluations.
- How it fits a clinical or practice workflow: The system integrates into the laboratory workflow by digitizing the traditional manual microscopic review of blood smears. Technicians prepare and load slides onto the miLab™ BCM device. The AI then performs an initial analysis, presenting results and flagged cells on a digital interface for review and validation by a qualified professional. This can potentially streamline the review process, especially for routine cases, and help prioritize complex cases for manual re-examination.
- Notable capabilities: Key capabilities include automated cell classification and counting, digital image archiving, and the ability to highlight atypical cells. It aims to standardize blood cell analysis and provide a consistent digital platform for morphology assessment.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered image cytometry
- Automates blood smearing, fixation, staining, digital imaging, and AI analysis
- Integrates Complete Blood Count (CBC) and Blood Morphology testing
- Delivers lab-quality hematology results at the point of care
- Requires small sample volume (~4-5u00b5L of blood)
- Provides rapid results (e.g., detect target cells in 15 min)
- Offers digital images of blood cells and pre-classification
- Enables remote result access
- Performs automated pre-hemocyte classification
- Detects subtle abnormal cells (e.g., immature granulocytes, blasts)
Use Cases
- Routine Complete Blood Count (CBC) and Blood Morphology analysis
- Point-of-care diagnostics in various medical environments
- Improving diagnostic access in low-resource settings and regions lacking infrastructure
- Early detection of blood cancers (e.g., leukemia)
- Monitoring patient conditions in regenerative medicine, including stem cell therapy
- Training and education for medical professionals
What Physicians Need to Know
LIS/LIMS Integration
miLabu2122 BCM stores and transmits all test results as digital data, enabling remote image storage and interpretation via the miLabu2122 platform. Users can access miLab data by connecting their PCs to the same local network as the miLab devices, suggesting network-based integration capabilities.
Supported Assay Types
The system performs comprehensive Complete Blood Count (CBC) and Blood Morphology (Peripheral Blood Smear) testing. It measures parameters including WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, and differential counts for NEUT, LYMPH, MONO, EO, BASO, IG, Blasts, Reactive Lymphocytes, nRBC, PLT Clumping, and Smudge cells. It can detect subtle abnormal cells like immature granulocytes (IG) and blasts, with potential for early detection of blood cancers such as leukemia.
QC/QA Features
miLabu2122 BCM standardizes core peripheral blood smear (PBS) processes, minimizing human variability and ensuring consistent diagnostic quality through automation. It supports quality control testing with dedicated QC slides (L1/L3, with future expansion to three levels) to verify system performance and reliability. The proprietary NGSI solid-based staining technology enhances staining consistency.
Result Interpretation AI
The platform features on-device AI (Noul-Net) that automatically analyzes cell images, performing AI-based pre-hemocyte classification and pre-classifying key CBC parameters and blood cell morphologies. This AI-powered analysis identifies morphological changes in blood cells, detects abnormal cells (e.g., atypical cells, blasts, abnormal white blood cells), and assists experts in accurate interpretation, providing faster and more consistent results than manual microscopy.
Critical Value Alerts
The system is designed to detect abnormalities, allowing for immediate morphology analysis when detected. It interprets CBC and WBC differential counts as normal, low, or high based on customizable reference intervals, which can trigger alerts for values outside these ranges. Its morphology-based alerts and digital imaging can help identify cases that might be missed by standard testing.
Instrument Interfaces
miLabu2122 BCM is an all-in-one diagnostic platform that utilizes a smart cartridge system for automated processing. It includes a built-in viewer for result review, with options for access via external monitors for remote consultation. Optional accessories include a miLabu2122 Slide Microscope Adapter for external microscopy and a miLabu2122 Local Storage Solution for expanded data storage.
Reference Range Intelligence
The device interprets CBC and WBC differential counts as normal, low, or high based on configurable reference intervals. The default settings for these intervals can be modified by the user.
Turnaround Time Impact
miLabu2122 BCM significantly reduces turnaround time, delivering results in minutes compared to hours or days for traditional methods. Each test takes approximately 20 minutes, with some reports indicating results within 15 minutes, enhancing both time and labor efficiency by automating the entire microscopy workflow.
Physician Tip
For physicians, miLabu2122 BCM offers rapid, AI-assisted blood cell morphology and CBC analysis, enabling quicker diagnostic decisions, especially for abnormal findings. Its ability to detect subtle abnormal cells like blasts and immature granulocytes can aid in the early identification of serious conditions, including leukemia. The digital imaging and remote access capabilities facilitate expert review and consultation, improving access to specialized diagnostics in various clinical settings. This tool can significantly reduce the workload on healthcare professionals while ensuring consistent and high-quality results.
miLabu2122 BCM generates digital data for all test results, supporting seamless integration into existing laboratory information systems (LIS) or laboratory information management systems (LIMS) through network connectivity. While specific protocols like HL7 are not explicitly detailed, the emphasis on digital data storage, remote accessibility, and the ability to customize reference ranges strongly implies compatibility for streamlined data flow within a laboratory's IT infrastructure.
Details
| Category | Lab & Diagnostics, Pathology AI |
| Pricing | Contact vendor — Cost-effective, aims to reduce infrastructure and labor costs. |
| Deployment | On-device AI solution, platform-based, utilizing miLab™ Platform device and miLab Viewer software for macOS and Windows. Designed to be compact and portable for various environments. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Noul secured FDA Class 1 medical device approval for its miLab Platform, miLab Cartridge BCM, and SafeFix in the U.S. in November 2024, indicating they meet stringent quality and safety standards. |
| Integrations | |
| EHR | Not specified |
| Specialties | Hematology, Laboratory Medicine, Pathology |
Ratings & Reviews
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Press & Coverage
Noul
Revolution of Automated Diagnostics Solution: NOUL's miLabu2122 BCM Expands to Europe
NOUL's miLabu2122 BCM has expanded into the European market, particularly Italy, to address the rising demand for automated diagnostic solutions for blood cancer detection. The AI-powered system offers rapid, accurate, and efficient blood cell analysis, aiming to revolutionize diagnosis and management.
2024-12
Noul
AI-Powered CBC Analyzer for Mexico: NOUL and Nihon Kohden Introduce miLabu2122 BCM
NOUL has partnered with Nihon Kohden to introduce the miLabu2122 BCM blood testing automation system in Mexico, aiming to enhance diagnostic efficiency and equity in the country's healthcare. The miLabu2122 BCM integrates Complete Blood Count (CBC) and Blood Morphology testing, automating the entire process for faster, more accurate results.
2025-06
RIGHT Foundation
Noul's miLab, First Product Listing Completed with US FDA u2013 RIGHT Foundation
Noul has completed establishment registration and device listing for its miLabu2122 Platform, including the miLabu2122 Cartridge BCM, with the U.S. FDA, marking a significant step towards entering the U.S. market. The company is actively pursuing full FDA approval for its miLab solutions, which also include malaria and cervical cancer diagnostics.
2024-11
Noul
Beyond Counting: How AI Is Closing the Gap with Expert Blood Cell Morphology - Noul
This article highlights how miLabu2122 BCM, an AI hematology analyzer, is transforming blood cell morphology analysis by providing a single, fully automated workflow for CBC and morphological classification. The system uses a dual-imaging strategy and AI algorithms to identify abnormal cells, aiming to improve early detection of blood cancers and reduce manual review.
2026-05
PR Newswire
Noul Supplies AI Diagnostic Platform miLabu2122 to Charitu00e9, Europe's Leading University Hospital - PR Newswire
Noul has secured an agreement to supply its miLabu2122 platform, including miLabu2122 BCM, to Charitu00e9 u2013 Universitu00e4tsmedizin Berlin, a leading European university hospital. This partnership aims to strengthen Noul's presence in advanced healthcare markets by demonstrating the platform's ability to reduce diagnostic delays and costs through automation and AI analysis.
2025-10
PR Newswire
Noul and Limbach Gruppe, Germany's top lab chain, to sign an agreement for the supply of miLabu2122 BCM - PR Newswire
Noul has signed an agreement with Limbach Group SE, Germany's largest lab chain, for the phased implementation of its AI-based hematology solution, miLabu2122 BCM, and malaria diagnosis solution, miLabu2122 MAL, in their laboratories. This agreement marks Noul's entry into the European market and aims to accelerate its expansion across the region.
2024-12
Noul
How Latin America Is Modernizing Diagnostics with AI-Powered Solutions - Noul
NOUL is expanding its miLabu2122 platform, including miLabu2122 BCM, into Latin America, with recent regulatory approval from ANVISA in Brazil. The company aims to address the region's demand for efficient diagnostic solutions by offering automated blood testing that enhances diagnostic efficiency and accessibility.
2025-07
PR Newswire
DNV SUPPORTS NOUL IN IVDR CERTIFICATION FOR AI-BASED MEDICAL DIAGNOSTIC PRODUCTS - PR Newswire
DNV is partnering with Noul to certify its miLabu2122 BCM cartridge for blood cell analysis, along with malaria and cervical cancer testing solutions, under the EU's In Vitro Diagnostic Medical Device Regulation (IVDR). This certification is crucial for global market access and ensures the safety and effectiveness of Noul's AI-based diagnostic products.
2026-01
Videos
Product demos, reviews, and walkthroughs for miLab™ BCM.
miLab BCMA Noul
Frequently Asked Questions
miLabu2122 BCM automates the entire process of Complete Blood Count (CBC) and Blood Morphology testing, from sample preparation to AI-powered analysis, within a single cartridge. This streamlines the workflow, providing results in under 20 minutes and reducing the need for extensive manual microscopic analysis.
miLabu2122 BCM utilizes a small blood sample (approximately 5 u00b5L) and generates high-definition digital images of white blood cells, red blood cells, and platelets, along with AI-powered pre-classification and various blood parameters. Physicians can review these results through a built-in viewer or external monitors, facilitating remote consultation and case analysis.
miLabu2122 BCM has secured CE-IVD marks for the European market and received FDA Class 1 medical device approval in the U.S. for the miLab Platform and miLab Cartridge BCM. While specific details on HIPAA or GDPR compliance are not explicitly provided in the search results, medical devices operating in these regions are generally expected to adhere to relevant data privacy regulations.
miLabu2122 BCM offers a fully automated, on-device AI solution that integrates CBC and blood morphology, designed to replace traditional peripheral blood smear (PBS) tests. It provides faster results, reduces human error, and requires minimal infrastructure and specialized personnel compared to conventional methods.
While specific pricing models are not detailed, miLabu2122 BCM's initial upfront costs are described as a fraction of what would typically be spent on a new blood testing lab, including staff training and employment. Additionally, it reduces reagent use by up to 99% and eliminates wastewater generation, contributing to operational cost savings.
The AI in miLabu2122 BCM provides pre-classification and analysis, enhancing accuracy in detecting abnormal cells. However, it is designed to assist experts, allowing skilled operators to verify, reclassify, and confirm results. This indicates that human oversight remains crucial for final diagnostic decisions, as the system aims to reduce workload and provide consistent results rather than fully replacing expert judgment.
The instructions for use indicate that using the miLabu2122 Cartridge BCM in ways not specified or without suitable qualification 'May cause misleading results.' The system is designed to assist and standardize the diagnostic process, but human verification of AI-generated pre-classifications is an integral part of the workflow. Therefore, the ultimate responsibility for diagnosis rests with the medical professional.
miLabu2122 BCM is suitable for adults and children aged 2 years and older. It requires only about 5 u00b5L of blood, making it especially suitable for pediatric and neonatal patients where blood collection can be challenging. The system also has the potential to improve early detection of blood cancers like leukemia through its AI-driven morphological analysis.
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| Last Verified: 2026-04-21 | First Added: 2026-04-21