HALO

by Nico.Lab B.V.  · Based in Netherlands →AI-powered clinical support for acute stroke diagnosis and management.
Emergency Medicine Neurology Radiology

Not disclosed
Regulatory Status Disclosed

Overview

Nico.Lab B.V.’s HALO is an AI-powered, cloud-based clinical support tool designed for rapid analysis of CT angiograms of the brain. It identifies imaging patterns suggestive of intracranial large vessel occlusion (LVO) and intracerebral hemorrhage (ICH) in patients suspected of stroke. HALO functions as a notification-only system, alerting medical specialists such as neurologists, radiologists, and emergency department physicians to suspected findings in parallel to the standard of care workflow. It is not a physician directory tool, but rather a diagnostic aid to facilitate timely evaluation and improve stroke care outcomes. HALO’s output is intended to support, not replace, primary diagnosis or clinical decisions by medical specialists. It is part of Nico.Lab’s broader StrokeViewer platform.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered Large Vessel Occlusion (LVO) detection
  • Intracerebral Hemorrhage (ICH) detection and volume quantification
  • Cloud-based image processing and analysis
  • Automated notifications to medical specialists
  • Remote review via compatible DICOM web viewer
  • Facilitates evaluation of brain vasculature on CT angiograms
  • Triage function for stroke patients
  • DICOM / PACS integration
  • Mobile diagnostic image viewing
  • Telemedicine collaboration tools

Use Cases

  • Rapid diagnosis of acute ischemic stroke (LVO)
  • Detection and quantification of intracerebral hemorrhage
  • Accelerated triaging of stroke patients
  • Improving time-to-treatment in stroke care
  • Clinical decision support for stroke specialists
  • Remote image review and collaboration

What Physicians Need to Know

Evidence Base
HALO Clinical AI products serve as decision-support tools for the analysis of breast, prostate, and lung cancer diagnostics, enabling standardized scoring of IHC slides for breast and lung cancer, and facilitating slide quality control and tissue macrodissection. HALO platforms integrate image management and quantitative image analysis to deliver standardized, reproducible tissue-based analysis.
Clinical Validation Studies
HALO AP Dx is FDA-cleared for primary diagnostic use with the Hamamatsu NanoZoomeru00ae S360MD Slide scanner in the USA. HALO AI Prostate is CE-marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. CellCarta utilizes HALO AI for the development of automated scoring algorithms for analyzing clinical trial samples, following validation according to rigorous standard operating procedures.
Differential Diagnosis Support
HALO Clinical AI products provide decision support for the analysis of breast, prostate, and lung cancer, and standardized scoring of IHC slides. This supports diagnosis within these specific pathology contexts.
Clinical Workflow Integration
HALO AP platforms offer tools and workflows for efficient image evaluation, management, and collaboration, automatically organizing images, metadata, and patient information into cases. HALO Clinical AI products are seamlessly integrated into the HALO APu00ae platform. The platform is designed for integration into standard operational workflows and LIMS ecosystems.
Decision Audit Trail
The HALO Link Compliance Add-on provides robust system-wide auditing and reason for change capture, recording every action that generates or alters data, including timestamps, event descriptions, original and new data values, and operator identity. HALO AP Dx and HALO APu00ae provide built-in compliance with FDA 21 CFR Part 11, HIPAA, and GDPR.
Physician Tip

Leverage HALO Clinical AI for standardized and efficient analysis of breast, prostate, and lung cancer pathology images. Utilize its seamless integration within the HALO AP platform to streamline diagnostic workflows, from image evaluation to case sign-out. Be mindful of the specific regulatory clearances (FDA, CE-IVDR) for diagnostic use in your region and with compatible scanning equipment.

HALO AP platforms are designed for seamless integration with existing pathology workflows and Laboratory Information Management Systems (LIMS). Indica Labs also offers dedicated integration and migration services to facilitate deployment. The platform is hosted in a secure and scalable cloud environment (AWS), ensuring accessibility and data management.

Details

Category Neurology AI, Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Not disclosed Contact vendor for pricing information
DeploymentCloud-based (Google Cloud Platform)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

HALO received FDA 510(k) Class II clearance (K211788 on 07/08/2021 and K200873 in November 2020) for detecting large vessel occlusions and for intracerebral hemorrhage detection and volume quantification.

Integrations
EHR Not specified
Specialties Emergency Medicine, Neurology, Radiology

What the Web Says

HALO by Nicolab appears to be a business management platform and an AI agent platform for customer experience, with some reviews also mentioning it as a feedback collection tool and an employee recognition program. Users generally praise its responsive customer support, ease of use, and ability to streamline various business processes. However, some users have noted issues with the complexity of certain workflows and high shipping costs for recognition gifts. There are also mentions of it being used in healthcare for communication among medical staff.

Overall: Positive

Strengths

  • Highly responsive and helpful customer support.
  • Easy to use interface and fast UI.
  • Effective for managing gifting and employee recognition programs.
  • Good for project collaboration and workflow management.
  • Helps integrate revenue-generating aspects of business and increase revenues.
  • Facilitates communication among medical staff, especially during night shifts.

Limitations

  • High shipping and freight charges for recognition gifts.
  • Online portal can be difficult to navigate or administer, with limitations on adding/removing employees.
  • Some processes, like procurement, are not easy to use.
  • Workflow management can be confusing for some users.
  • Limited options for customizing feedback processes.
  • Potential for slow website performance (though this may be due to local wifi).

Based on reviews from: G2, Capterra

Last updated: 2026-07-19

Ratings & Reviews

No reviews yet. Be the first to review this tool!

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Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

Reach Markets
How this AI-enabled medtech helps with stroke emergencies - News - Reach Markets
Nicolab, an AI-driven medical technology company, is revolutionizing stroke diagnosis in emergency care with its StrokeVieweru00ae HALO, which has received FDA clearance and is being rolled out globally. The company has also partnered with Philips, a leading healthcare company, to co-develop products and integrate HALO into Philips' Neuro Angiosuite and Azurion platform.
2024-04
PMC (PubMed Central)
Systematic review of commercial artificial intelligence tools for the detection and volume quantification in intracerebral hemorrhage - PMC
This systematic review, updated in March 2025, evaluates commercial AI tools for intracerebral hemorrhage (ICH) detection and quantification, including Nicolab B.V.'s HALO, which is FDA 510(K) Class II and CE-certified. The review highlights that while all identified tools were certified for ICH detection, volume quantification remains less established with variable performance.
2025-07
PLOS Digital Health
Performance evaluation methods for improvements at post-market of artificial intelligence/machine learning-based computer-aided detection/diagnosis/triage in the United States | PLOS Digital Health
This research article from March 2023 discusses performance evaluation methods for AI/ML-based computer-aided detection/diagnosis/triage devices in the US, noting that HALO (NICO-Lab B.V.) received a 510(k) in November 2020 for triaging large vessel occlusion and had an application submitted in June 2021 to add Philips CT angiogram support.
2023-03
SciOpen
Implications of Artificial Intelligence in Stroke Intervention and Care - SciOpen
A review from April 2025 discusses the implications of AI in stroke care, mentioning HALO by NICo-Lab B.V. as an FDA-approved AI/ML-enabled technology that assists in the processing, analysis, and identification of large vessel occlusion (LVO) in anterior circulation from contrast-enhanced CT angiograms.
2025-04
PMC (PubMed Central)
Artificial Intelligence and Machine Learning in the Diagnosis and Management of Stroke: A Narrative Review of United States Food and Drug Administration-Approved Technologies - PMC
This narrative review from May 2023 provides an overview of FDA-approved AI/ML technologies for stroke diagnosis and management, listing NICo-Lab B.V.'s HALO with its 510(k) approval in November 2020 for LVO identification.
2023-05
ResearchGate
Revolutionizing Acute Stroke Care: A Review of Food and Drug Administration-Approved Software as Medical Devices for Stroke Triage - ResearchGate
A November 2024 review on FDA-approved Software as Medical Devices for stroke triage highlights Nicolab B.V.'s HALO, noting its high sensitivity and specificity for ICA, M1, and M2-LVO detection with a rapid processing time.
2024-11
Newswire
NICO.LAB Ready to Revolutionize U.S. Stroke Care Following FDA Clearance
NICO.LAB announced in November 2020 that its StrokeViewer LVO, approved as HALO under FDA submission number K200873, is ready to revolutionize U.S. stroke care. The cloud-based AI solution supports physicians in emergency stroke settings by quickly detecting large vessel occlusions.
2020-11
FDA
NiCo-Lab B.V. November 20, 2020 Roujuan Zhang Consultant MD Squared B.V. High Tech Campus 29 Eindhoven, 5858AE NETHERLANDS R - accessdata.fda.gov
This FDA 510(k) premarket notification document from November 2020 details the indications for use of HALO, a cloud-based image processing software application using AI algorithms to analyze patient imaging data for suspected stroke, facilitating the evaluation of brain vasculature.
2020-11

Videos

Product demos, reviews, and walkthroughs for HALO.

View all on YouTube

Frequently Asked Questions

HALO systems, such as the AI-powered medical practice platform or the Health Application Lightweight Protocol (HALO), are designed for seamless integration with existing EHRs and clinical systems. They can automate tasks like patient intake, note generation, and claims processing, or enable secure 'plug and play' interoperability for third-party digital health applications directly within the EMR.
Many HALO platforms prioritize data security and regulatory compliance. For instance, Halo Medical Solutions' AI platform is HIPAA and SOC-2 compliant, safeguarding patient data in full alignment with healthcare privacy and security standards. Similarly, Halo Medical Technologies' ultrasound systems offer EMR integration with complete compliance with the latest privacy and information security best practices.
While HALO aims to streamline workflows, potential challenges could include the initial setup and integration complexity with diverse existing systems, or ensuring consistent user adoption across a practice. As with any IT system, occasional technical issues or crashes, though quickly addressed, could temporarily disrupt workflows.
HALO differentiates itself by offering integrated solutions that can range from automating administrative tasks and clinical documentation to enabling secure, real-time communication and interoperability between various digital health tools and EHRs. Unlike fragmented systems, HALO aims to provide a unified platform to reduce administrative burden and improve care coordination.
Specific pricing for HALO solutions is not consistently detailed publicly and often depends on the particular HALO system (e.g., diagnostic platform, AI practice management, or EMR integration framework) and the scale of implementation. Practices using certain HALO systems have reported significant financial benefits through increased revenue capture and reduced administrative costs, suggesting a value-based or subscription model.
HALO systems are designed with features to enhance accuracy, such as automated data transfer from medical devices to EHRs to minimize manual entry errors. Platforms like Halo Medical Technologies' ultrasound systems auto-populate EMR-ready reports with all data, images, and interpretations. The Health Application Lightweight Protocol (HALO) also improves data sharing to ensure providers have access to up-to-date, accurate patient information.

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