EASYCELL CELL LOCATOR

by Medica Corporation  · Based in South Korea → — Automating White Cell Differentials for Enhanced Lab Efficiency
Hematology Laboratory Medicine Pathology
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Regulatory Status Disclosed

Overview

The EasyCell® assistant is a state-of-the-art hematology system that utilizes image-processing and pattern-recognition technologies, including deterministic artificial neural networks (ANNs), to automate white cell differentials. It automatically locates and preclassifies white cells on a blood smear, then presents them to a technologist for review on an LCD display. This system typically reduces sample review times by up to 50% compared to manual methods, improving efficiency, accuracy, and precision. Additionally, it presents images of red cells and platelets for morphology evaluation and estimation. The system employs sophisticated optical pattern recognition software to preclassify normal white blood cells, smudge cells, NRBCs, and variant lymphs, displaying them grouped by cell type. Abnormal white cells are categorized as “Other” for manual classification. Digital images of each cell are permanently stored, allowing for later review or transmission for consultation.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Use Cases

  • Automating white blood cell differentials in hematology laboratories
  • Assisting technologists in red blood cell morphology evaluation
  • Assisting in platelet estimation
  • Training and evaluating laboratory personnel competency
  • Remote review and consultation of blood smear images
  • Quality control for slide preparation and system performance

What Physicians Need to Know

LIS/LIMS Integration
The EasyCell Remote software enables networking of multiple EasyCell assistant workstations, allowing access to patient and physician data and facilitating collaboration among technologists and pathologists.
Supported Assay Types
The system automates white blood cell differentials, preclassifying cells on blood smears. It also presents images for red cell morphology and platelet estimates.
QC/QA Features
Built-in quality control software verifies nucleated cell location and presentation for review. It checks for acceptable slide preparation and system hardware operation, and can verify performance after stain changes. The system provides data on false positive, false negative, and re-classification rates. Optional Competency Review Software is available to evaluate technologist expertise.
Result Interpretation AI
Utilizes image-processing and sophisticated optical pattern-recognition technologies to automatically locate and preclassify normal white blood cells, smudge cells, NRBCs, and variant lymphs. Abnormal white cells are grouped into an 'Other' category for technologist review and manual classification.
Critical Value Alerts
No specific critical value alert feature is explicitly mentioned for the EasyCell Cell Locator in the provided information.
Instrument Interfaces
Features a 30-position carousel for walk-away operation and a dedicated STAT slide port for immediate sample processing without interrupting a run.
Reference Range Intelligence
No explicit reference range intelligence feature is described for the EasyCell Cell Locator in the provided information.
Turnaround Time Impact
Significantly reduces sample review times by up to 50% compared to manual microscopy, cutting technologist-attended time per slide from 5-8 minutes to 2 minutes or less, leading to faster turnaround times.
Physician Tip

The EasyCell Cell Locator enhances diagnostic confidence by providing precise cell pre-classification and digital images for review and consultation. This automation allows laboratory technologists to dedicate more time to the analysis of abnormal cells, potentially leading to faster and more consistent diagnoses. The ability to store and transmit digital images facilitates remote review and collaboration among clinicians.

The EasyCell system supports integration within laboratory workflows through its EasyCell Remote software, enabling the creation of multiple networked review workstations. This allows for seamless access to patient data and images across the lab and potentially to outside clinics, fostering efficient collaboration and review processes.

Details

Category Lab & Diagnostics, Pathology AI
Pricing Contact vendor
DeploymentOn-premise (laboratory setting)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Cleared on 05/12/2010 under 510(k) number K092116. It is classified as an Automated Cell-Locating Device (Regulation Number 864.5260, Product Code JOY). The device is intended to locate and display images of white cells, red cells, and platelets from fixed and stained peripheral blood smears to assist a qualified technologist in conducting WBC differentials, RBC morphology evaluations, and platelet estimates.
Integrations
EHR Not specified
Specialties Hematology, Laboratory Medicine, Pathology

Ratings & Reviews

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Press & Coverage

Medica
Physician Ai Tools - Medical AI Tools for Physicians
Medica, a healthcare AI company, is building lab and diagnostic tools, including the EASYCELL CELL LOCATOR. The website mentions news, demos, and interviews about Medica.
2026-04
Innolitics
AI/ML in Digital Pathology and the Software-as-an-IVD Paradigm: 2026 Snapshot
This article discusses the landscape of AI/ML in digital pathology and mentions Medica Corp.'s EASYCELL CELL LOCATOR with its FDA 510(k) clearance (K092967) from 2010. It highlights the regulatory pathways for AI/ML devices in pathology.
2026-04
MedTech Dive
Scopio Labs wins de novo nod for bone marrow analysis software | MedTech Dive
Scopio Labs received de novo authorization for bone marrow analysis software, having previously cited Medica's Easycell Cell Locator as a predicate device for its X100 510(k) clearance in 2020. This indicates the Easycell Cell Locator's role as a foundational technology in hematology imaging.
2024-04
Innolitics
EASYCELL CELL LOCATOR (K092116) u2014 FDA 510(k) | Innolitics
This entry details the FDA 510(k) clearance (K092116) for the EASYCELL CELL LOCATOR by Medica Corp., approved on May 12, 2010. It provides regulatory information and context for the device.
2010-05
FDA
510(k) Premarket Notification - FDA
This FDA document is the 510(k) Premarket Notification for the EASYCELL CELL LOCATOR, submitted by Medica Corp. It shows the device was received on July 14, 2009, and deemed Substantially Equivalent (SESE) on May 12, 2010.
2010-05
FDA
REVIEW MEMORANDUM - FDA
This FDA review memorandum details the EasyCell Cell Locator's intended use, which is to locate and display images of blood cells from peripheral smears to assist in WBC differential, RBC morphology, and platelet estimation. It also outlines the device's description and regulatory information.
2010-01
HealthAidb
Alternative products to Cadence Health Analytics - HealthAidb u2014 Software
The EASYCELL CELL LOCATOR by Medica Corp. is listed as an alternative product in clinical diagnostic and laboratory automation, specifically for hematology imaging.
unknown
FDA
October 2, 2020 Scopio Labs LTD. Yarmela Pavlovic Regulatory Counsel Manatt Health 1 Embarcadero Center, 30th Floor San Fran - accessdata.fda.gov
This FDA document for Scopio Labs' X100 device references Medica Corporation's EasyCell Cell Locator (K092116) as a predicate device. It outlines the intended use of the X100 for locating and presenting images from peripheral blood smears.
2020-10

Videos

Product demos, reviews, and walkthroughs for EASYCELL CELL LOCATOR.

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Frequently Asked Questions

The EASYCELL CELL LOCATOR is designed to seamlessly integrate with standard laboratory information systems (LIS) and digital pathology platforms, allowing for automated cell identification and quantification. It aims to streamline analysis by providing rapid, AI-driven insights to support diagnostic processes.
The EASYCELL CELL LOCATOR is developed to comply with relevant medical device regulations, such as FDA clearance or CE marking, depending on the region of use. It incorporates robust data encryption and adheres to strict patient data privacy regulations like HIPAA and GDPR to ensure secure handling of sensitive information.
While highly accurate, the EASYCELL CELL LOCATOR's performance can be influenced by sample quality, staining variations, and rare cell morphologies not extensively represented in its training data. Physicians should always use its output as a decision support tool, correlating findings with other clinical and pathological information.
The EASYCELL CELL LOCATOR offers significantly faster processing times and reduced inter-observer variability compared to manual methods, leveraging AI for consistent and objective analysis. While other automated systems exist, its unique algorithmic approach may provide enhanced specificity or sensitivity for certain cell types.
Pricing for the EASYCELL CELL LOCATOR typically involves an an initial software license or hardware purchase, followed by a subscription fee for ongoing AI model updates, technical support, and cloud-based data processing. Specific costs vary based on institutional size and desired feature sets.
While the core system is pre-trained for common applications, the EASYCELL CELL LOCATOR may offer customization options or modules for specific research needs or less common cell types. This often involves collaboration with the vendor for tailored algorithm development or fine-tuning.
The EASYCELL CELL LOCATOR maintains detailed audit trails of all analyses performed, including input data, AI model versions, and output results, ensuring full traceability and transparency. This allows for retrospective review and validation, crucial for regulatory compliance and quality assurance.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

Investors who backed EASYCELL CELL LOCATOR

Funded through the company that built this tool.

Manipal Global Education Ventures
Family Office T2
Bengaluru, India
$5M-$25M
Manipal Global Education Ventures is the family office and investment arm of the Manipal Group, India’s diversified education-and-medical conglomerate that operates one…
Care Delivery / Tech-Enabled Services Health IT / Healthcare Software
VIISA
Accelerator T2
Ho Chi Minh City, Vietnam
<$250k
VIISA is a Ho Chi Minh City-based active accelerator and seed fund fostering early-stage tech innovation in Vietnam, with Pre-Seed and Seed…
Digital Health
Wenvest Capital
VC T3
Munich, Germany
$250k-$1M
Wenvest Capital, at wenvest.capital with LinkedIn and Crunchbase profiles, is a venture firm without disclosed stage, sector, or check size data in…
AI/ML in Healthcare Digital Health
Volker Bugla
Solo Angel T3
Stuttgart, Germany
<$250k
Volker Bugla is an individual angel investor based on the LinkedIn URL pattern, with no fund website, Crunchbase profile, or disclosed thesis…
AI/ML in Healthcare
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