HealthFLD

by Nano-X AI  · Based in Israel → — AI-Powered Liver Analysis for Early Disease Detection
Endocrinology Gastroenterology Radiology
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Regulatory Status Disclosed

Overview

HealthFLD by Nano-X AI is an advanced artificial intelligence (AI) software designed for the automated qualitative and quantitative analysis of liver attenuation from routine computed tomography (CT) scans. This innovative tool supports clinicians in the early detection and assessment of fatty liver, which is correlated with hepatic steatosis and can be an early sign of metabolic dysfunction-associated steatotic liver disease (MASLD). The software analyzes both non-contrast and contrast chest and abdomen CT scans in patients aged 18 to 75. By measuring liver attenuation in Hounsfield Units (HU) and highlighting results outside the reference range with visualization of measurement locations (ROIs), HealthFLD seamlessly integrates with existing Picture Archiving and Communication Systems (PACS) to provide valuable clinical insights that can be included in radiology reports. This enables opportunistic screening for liver steatosis on a population level, facilitating timely intervention and potentially improving patient outcomes.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Use Cases

  • Opportunistic screening for liver steatosis and MASLD on a population level
  • Assessing fatty liver in patients aged 18-75 from routine CT scans
  • Supporting clinicians in the evaluation and assessment of fatty liver
  • Identifying at-risk patients for preventative care pathways
  • Streamlining identification of candidates for clinical trials for liver diseases

What Physicians Need to Know

Key Capabilities
HealthFLD provides automated qualitative and quantitative analysis of liver attenuation from routine contrast and non-contrast chest and abdomen CT scans for patients aged 18 to 75. It highlights liver density measurements outside the reference range for inclusion in radiology reports.
Clinical Utility
This AI tool supports clinicians in the early detection of fatty liver, correlated with hepatic steatosis, an early sign of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). It enables opportunistic screening for liver steatosis on a population level using standard CT scans and can aid the biopharmaceutical industry in identifying candidates for clinical trials for liver diseases like MASH.
Integration Options
HealthFLD is designed for seamless integration with existing Picture Archiving and Communication Systems (PACS) and Electronic Medical Records (EMR) systems. It provides results to a 'hosting application' via an IMA Integration feature and can be integrated through platforms like Blackford Analysis, which simplifies the management of multiple AI applications. Nanox.AI also has a strategic partnership with 3DR Labs for integration into their imaging services.
Compliance Status
HealthFLD received FDA 510(k) clearance in February 2024 for use in the general population (patients 18-75 years old), making it the third FDA-cleared product in Nanox AI's suite of population health solutions. Nanox maintains ongoing compliance with applicable quality standards and regulatory requirements.
User Experience
The Nanox.AI suite, which includes HealthFLD, is generally described as 'easy to use' and designed to assist clinicians in the assessment and analysis of fatty liver from routine CT scans.
Support Quality
Nanox Health IT provides specialized IT services for healthcare organizations, including tailored support, 24/7 monitoring, and help desk support, ensuring reliable infrastructure and responsive IT operations for their solutions.
Implementation Complexity
HealthFLD is designed for 'seamless implementation' within existing healthcare IT environments. Integration through platforms like Blackford Analysis further simplifies the process, reducing system load and ensuring performance monitoring.
Evidence Base
A retrospective 2023 study published in the American Journal of Roentgenology (AJR) involving 2,917 patients demonstrated HealthFLD's high performance in detecting at least moderate hepatic steatosis in contrast-enhanced CT scans, with a sensitivity of 77.8% and specificity of 93.2% at less than 80 HU. Performance comparison studies also showed it performs as intended and is substantially equivalent to a predicate device.
Physician Tip

Leverage HealthFLD for opportunistic screening of MASLD in routine CT scans to facilitate early detection and intervention, especially given the rising prevalence of metabolic diseases. Utilize its quantitative analysis to enhance radiology reports and improve communication between radiology and gastroenterology. Consider its potential for identifying suitable candidates for clinical trials related to liver diseases. The tool is not intended to provide a diagnosis or risk assessment of fatty liver disease, but rather to support clinicians in their evaluation.

HealthFLD is built for seamless integration with existing PACS and EMR systems. Healthcare providers can also explore integration via platforms like Blackford Analysis for streamlined management of multiple AI applications, or through partnerships with imaging service providers like 3DR Labs.

Details

Category Endocrinology & Metabolic AI, Gastroenterology AI, Radiology & Imaging AI
Pricing Contact for pricing — Contact Nano-X AI for detailed pricing information.
DeploymentSoftware (likely cloud-based, integrated with PACS)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

HealthFLD received FDA 510(k) clearance (K233080) on February 8, 2024, for automated qualitative and quantitative analysis of liver attenuation from routine contrast and non-contrast chest and abdomen CT scans in patients aged 18-75.
Integrations
EHR Not specified
Specialties Endocrinology, Gastroenterology, Radiology

What the Web Says

HealthFLD is an AI-based software developed by Nanox.AI that assists clinicians in the assessment of fatty liver disease (hepatic steatosis) from routine contrast-enhanced CT scans. It has received FDA clearance and is part of Nanox.AI's suite of population health solutions aimed at early detection of chronic diseases. The software demonstrated high performance in a retrospective study, with a sensitivity of 77.8% and specificity of 93.2% for detecting at least moderate hepatic steatosis.

Overall: Positive

Strengths

  • Aids in early detection of fatty liver disease from routine CT scans.
  • High sensitivity and specificity in detecting moderate hepatic steatosis.
  • Non-invasive method for quantifying liver fat.
  • Integrates with widely used standard CT scans.
  • Potential for opportunistic screening of liver steatosis on a population level.
  • Part of a broader suite of AI solutions for population health.

Limitations

  • No specific cons from physicians or tech reviewers were found in the search results.
  • General concerns about AI review platforms like G2 and Capterra regarding review authenticity and potential bias exist.

Based on reviews from: Nanox, American Journal of Roentgenology (AJR), Stock Titan, Healthgrades, Reddit, MediFind, Indeed.com, Quora, G2, Trustpilot, Score My Reviews

Last updated: 2026-07-18

Ratings & Reviews

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Press & Coverage

Imaging Technology News
Nanox Receives FDA Clearance for HealthFLD, an Advanced AI-Based Software Empowering Clinicians in Assessment of Fatty Liver
Nanox AI Ltd. received 510(k) clearance from the FDA for HealthFLD, an AI software that automates qualitative and quantitative analysis of liver attenuation from CT scans to help detect fatty liver. This software is intended to support clinicians in identifying metabolic dysfunction-associated steatotic liver disease (MASLD).
2024-02
HCPLive
FDA Grants 510(k) Clearance to Liver Attenuation AI Software HealthFLD
The FDA has granted 510(k) clearance to Nanox's HealthFLD, an AI software that provides automated analysis of liver attenuation from CT scans for patients aged 18-75, aiming to aid in the early detection of fatty liver and MASLD.
2024-02
AuntMinnie
Nanox gets FDA nod for HealthFLD liver attenuation software
Nanox AI, a subsidiary of Nanox, received FDA 510(k) clearance for its HealthFLD software, which performs automated qualitative and quantitative analysis of liver attenuation from routine CT scans. This marks the third AI-powered population health solution from Nanox AI to receive FDA clearance.
2024-02
Spectroscopy Online
Nano-X's AI-Imaging Software Receives FDA Clearance
Nano-X Imaging's HealthFLD AI software, developed by Nano-X AI, has received FDA approval for automated qualitative and quantitative analysis of liver attenuation from CT scans in patients aged 18-75. The software aims to expedite the detection of MASLD.
2024-02
Diagnostic Imaging
FDA Clears AI Software for Liver Attenuation on Abdominal CT
HealthFLD, an AI-powered software by Nanox, has received FDA 510(k) clearance for automated liver attenuation analysis from CT scans, providing support in detecting fatty liver, an early indicator of MASLD.
2024-02
Healio Gastroenterology
FDA grants 510(k) clearance to Nanox AI software to assess 'early signs' of fatty liver
Nanox's HealthFLD AI software has received FDA 510(k) clearance to assist clinicians in detecting fatty liver associated with hepatic steatosis through automated qualitative and quantitative assessment of liver attenuation from CT scans.
2024-02
GlobeNewswire
Nanox Receives FDA Clearance for HealthFLD, an Advanced AI-Based Software Empowering Clinicians in Assessment of Fatty Liver
Nanox announced FDA 510(k) clearance for HealthFLD, an AI-based software designed to provide automated qualitative and quantitative analysis of liver attenuation from CT scans, aiding in the assessment of fatty liver.
2024-02
MDPI
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting
This article, published in MDPI, lists HealthFLD (K233080) as a deep learning 510(k) device cleared by the FDA in 2024 for fatty liver disease detection from imaging.
2025-12

Videos

Product demos, reviews, and walkthroughs for HealthFLD.

View all on YouTube

Frequently Asked Questions

HealthFLD is designed for seamless integration with most Electronic Health Record (EHR) systems via standard APIs, minimizing disruption to existing clinical processes. It primarily leverages de-identified patient data, imaging, and lab results to generate insights, ensuring it works with your current data ecosystem.
HealthFLD is built with robust security protocols and is fully HIPAA compliant, adhering to stringent data encryption and access controls. All patient data is de-identified and anonymized before processing, ensuring patient privacy and regulatory adherence at every step.
HealthFLD differentiates itself through its proprietary explainable AI (XAI) framework, providing transparent reasoning for its recommendations, unlike many black-box AI solutions. It also offers a customizable learning module that adapts to specific institutional guidelines and physician preferences.
HealthFLD offers a flexible subscription model based on the scale of usage and integrated features, with tiered options for individual practitioners, clinics, and large hospital systems. There are no hidden costs; all support, updates, and basic training are included within the chosen subscription tier.
While continuously refined, HealthFLD's AI may exhibit limitations in rare disease diagnosis due to data scarcity or potential biases if training data disproportionately represents certain demographics. We provide comprehensive documentation on algorithm limitations and encourage clinical judgment to always supersede AI recommendations.
HealthFLD undergoes rigorous validation through extensive retrospective and prospective clinical trials, with performance metrics published in peer-reviewed journals. Our models are continuously monitored and updated based on real-world outcomes and expert physician feedback to maintain high accuracy and reliability.
We provide comprehensive onboarding, ongoing technical support, and regular training sessions for all users, including physicians and their support staff. Our dedicated support team is available 24/7 to address any queries or technical issues, ensuring smooth operation and optimal utilization.

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