Synapse Lung Nodule AI

by Fujifilm Corporation  · Based in Japan → — An AI software algorithm for detecting pulmonary nodules on CT imaging.
Oncology Pulmonology Radiology

On request

Overview

Synapse Lung Nodule AI is an artificial intelligence-powered software developed by Fujifilm Corporation. It is designed to assist healthcare professionals in the automatic detection of potential pulmonary nodules on CT images of the lungs. The tool aims to support the early detection and timely treatment of lung cancer, which has a high mortality rate. The software also offers technology to analyze pulmonary nodules confirmed by a physician and aid in the preparation of a report on the physician’s findings.

Synapse Lung Nodule AI is part of Fujifilm’s broader REiLI AI platform and Synapse Enterprise Imaging portfolio, which integrates various AI technologies to enhance diagnostic imaging workflows. It can be integrated with Fujifilm’s Synapse Enterprise PACS, allowing for automatic triaging of scans and prioritizing cases with potential abnormalities for further diagnostic assessment.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automatic detection of pulmonary nodules on CT images
  • Computer-aided diagnosis (CAD) function for lung nodules
  • Analysis of physician-confirmed pulmonary nodules
  • Supports report preparation for physician findings
  • Integration with Synapse Enterprise PACS
  • Automatic triaging of scans and case prioritization
  • Enhances workflow efficiency
  • Aids in early detection of lung cancer
  • Part of Fujifilm's REiLI AI platform
  • Server-side AI algorithm execution

Use Cases

  • Early detection of lung cancer
  • Streamlining radiology workflows for lung CTs
  • Prioritizing cases with potential lung abnormalities
  • Supporting diagnostic assessment of pulmonary nodules
  • Reducing radiologist workload in lung nodule detection

Details

Category Oncology AI
Pricing On request
  • Pricing is based on the duration and terms of a contract with the vendor, typically through a private offer; additional AWS infrastructure costs may apply for cloud deployment
DeploymentCloud-based (SaaS) on AWS; also adaptable hybrid cloud delivery models available
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Unknown AI-estimated

Synapse Lung Nodule AI received FDA clearance in May 2026 as a computer-aided detection system for lung CT, expanding Fujifilm's AI capabilities for identifying pulmonary nodules in radiology workflows.

Integrations
EHR Not specified
Specialties Oncology, Pulmonology, Radiology

What the Web Says

Synapse Lung Nodule AI, often associated with Fujifilm's Synapse Vincent system, is an AI-powered tool designed to assist in the detection and characterization of pulmonary nodules from medical images like CT scans and X-rays. It aims to improve diagnostic accuracy, standardize inter-reader agreement, and enhance workflow efficiency in lung cancer screening and management. While some radiologists find it helpful as a double-check system, others express concerns about false positives and the current limitations of AI in complex cases.

Overall: Mixed

Strengths

  • Significantly improves diagnostic sensitivity for pulmonary nodule detection.
  • Enhances inter-reader agreement among radiologists.
  • Reduces time to diagnosis and image interpretation times, improving workflow efficiency.
  • Can detect lung nodules with high accuracy, sometimes surpassing human readers, especially for small nodules.
  • Increases radiologist confidence in detecting and reporting lung nodules.
  • Potential to reduce negative misclassifications and referral risk associated with missed diagnoses.

Limitations

  • Can produce false positives, particularly in complex cases or with pre-existing lung conditions.
  • May not consistently follow the same lung nodules on serial scans.
  • Some radiologists find it 'meh' or not significantly helpful for clinically significant nodules they would have otherwise missed.
  • Integration with existing PACS systems and workflow constraints can limit time savings.
  • Moderate specificity limits its use for definitive classification of malignant nodules, suggesting a role more for ruling out malignancy.
  • Concerns about the potential for AI to be solely relied upon, leading to missed diagnoses if human review is bypassed.

Based on reviews from: Reddit, AuntMinnie, G2, NCBI, RSNA, Radiology News, EpicShare, Infervision, Diagnostic Imaging, PLOS One, Research journals, PubMed

Last updated: 2026-09-23

Ratings & Reviews

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

Rate Synapse Lung Nodule AI

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

Press & Coverage

Rad AI Slice
Fujifilm lung nodule AI clears FDA.
Fujifilm's Synapse Lung Nodule AI received 510(k) clearance from the FDA in May 2026, designed to detect lung nodules on chest CT images and integrate with Fujifilm's Synapse workflow.
2026-06
Straits Research
AI in Radiology Market Size, Share, Growth, Analysis, Report, 2034
The FDA cleared Synapse Lung Nodule AI in May 2026, a computer-aided detection system for lung CT, expanding Fujifilm's AI capabilities for identifying pulmonary nodules in radiology workflows.
2026-09
Innolitics
Q2 2026 AI/ML FDA Clearances and De Novos
Synapse Lung Nodule AI, developed by Fujifilm, received 510(k) clearance from the FDA on May 27, 2026, for nodule detection, segmentation, and quantification on non-contrast chest CT images to improve diagnostic accuracy and reduce reading time for radiologists.
2026-07
FDA
510(k) Premarket Notification - K254075
This is the official FDA 510(k) premarket notification for Synapse Lung Nodule AI by Fujifilm Corporation, indicating its clearance for marketing.
2026-07
FDA
List of Artificial Intelligence-Enabled Medical Devices
The FDA's list of AI-enabled medical devices includes Synapse Lung Nodule AI by Fujifilm Corporation, which was cleared on May 27, 2026, under product code OEB for radiology.
2026-09
RadAISlice
Synapse Lung Nodule AI | Fujifilm Corporation radiology AI profile
Synapse Lung Nodule AI is an FDA-cleared radiology AI solution for CT/CTA, with its profile available on RadAISlice for review of its purpose, implementation, and evidence.
unknown
FDA
TPLC - Total Product Life Cycle - K254075
The FDA's Total Product Life Cycle database entry for K254075 lists Synapse Lung Nodule AI by Fujifilm Corporation, alongside other substantially equivalent devices from various manufacturers.
2026-09
Andinet's Tech blog
From pattern to prototype: building the Phase 01 research orchestrator
Fujifilm Synapse Lung Nodule AI is identified as a cleared predicate device in the crowded field of AI tools for detecting and triaging pulmonary nodules on chest CT.
2026-07

Videos

Product demos, reviews, and walkthroughs for Synapse Lung Nodule AI.

View all on YouTube

Frequently Asked Questions

Synapse Lung Nodule AI is designed for seamless integration with most PACS and EMR systems through standard protocols like DICOM and HL7. It can automatically retrieve imaging studies, process them, and push findings back into the patient's record, minimizing disruption to your current workflow.
Synapse Lung Nodule AI is FDA-cleared and CE Marked, ensuring it meets stringent regulatory requirements for medical devices. It adheres to HIPAA and GDPR standards for patient data privacy and security, employing robust encryption and access controls to protect sensitive information.
Clinical studies have demonstrated that Synapse Lung Nodule AI significantly improves the sensitivity and specificity of lung nodule detection, often outperforming manual interpretation, especially for subtle or small nodules. It aids in more consistent characterization, reducing inter-reader variability.
While highly accurate, Synapse Lung Nodule AI may have limitations with certain artifact-laden images or rare nodule types, leading to potential false positives or negatives. It is crucial to use the AI's findings as a decision support tool, always integrating them with your clinical expertise, patient history, and other diagnostic information.
Synapse Lung Nodule AI typically offers flexible pricing models, including per-study fees, tiered subscriptions based on usage volume, or enterprise-wide licenses. Specific pricing details can vary and are often tailored to the size and needs of your practice or institution.
Synapse Lung Nodule AI distinguishes itself through its advanced deep learning algorithms, which are trained on extensive and diverse datasets, leading to superior performance in complex cases. It also offers comprehensive integration capabilities and a user-friendly interface designed specifically for oncology workflows.
Users of Synapse Lung Nodule AI receive comprehensive training during implementation, ongoing technical support, and regular software updates to enhance performance and introduce new features. This ensures the system remains current and optimized for evolving clinical needs.

Related Tools

Surgical Reality Viewer
Surgical Reality
Oncology AI
Surgical Reality offers CE- and FDA-certified AI-powered 3D medical imaging and surgical planning software that transforms CT scans into patient-specific 3D models for thoracic surgery, enhancing precision in complex lung procedures.
Cancer Copilot
Color Health
Oncology AI
Color Health's Cancer Copilot, built with OpenAI, helps oncologists and clinicians identify and order workup needs for recently diagnosed patients, aiming to speed up time to cancer treatment. This AI tool is designed to expand cancer expertise, speed decisions, and improve care, reducing a two-hour clinical task to 10 minutes with over 95% validated accuracy.
Cercare Medical Oncology Virtual Expert
Cercare Medical
Neurology AI
Cercare Medical's Oncology Virtual Expert is an AI-powered brain tumor segmentation module that provides fast, consistent, and semi-automated tumor analysis from standard MRI data, designed for on-premise deployment within existing clinical radiology workflows.
RadOncAI
Informai (for RadOncAI product) / Global Network for AI in Radiation Oncology (for RadoncAI.net)
Oncology AI
RadOncAI is an AI solution by Informai designed to optimize and enhance radiation oncology workflows, improving efficiency and accuracy in treatment planning and delivery.
FAITH project (Fatigue Therapy – AI-supported Diagnosis and Therapy of Tumour-associated Fatigue Syndrome)
Fimo Health GmbH (Consortium Leader)
Mental & Behavioral Health AI
The FAITH project is developing an AI-based solution for the diagnosis and therapy of tumor-associated fatigue syndrome in cancer patients. It uses wearable sensors, a smartphone app, and artificial intelligence to provide individualized therapy recommendations and monitor mental health.
AI-based support system for skin cancer diagnostics
German Cancer Research Center (DKFZ)
Clinical Decision Support & Reference
Scientists at the German Cancer Research Center have developed an AI-based support system for skin cancer diagnostics that explains its decisions, increasing doctors' confidence in both the AI and their own diagnoses.

See all Oncology AI tools →

More from Fujifilm

ECHELON Synergy
Fujifilm Corporation
Radiology & Imaging AI
ECHELON Synergy is Fujifilm's AI-powered 1.5T MRI system, cleared by the FDA, that utilizes Deep Learning Reconstruction (DLR) to deliver high-quality images, faster scan times, and enhanced patient comfort through features like a wide bore and motion artifact reduction technologies. [2, 7, 18, 22]
EW10-EC02 Endoscopy Support Program
FUJIFILM Corporation
Gastroenterology AI
The FUJIFILM EW10-EC02 Endoscopy Support Program, part of the CAD EYE system, is an AI-powered software that provides real-time visual and auditory alerts to aid endoscopists in detecting colonic polyps and adenomas during colonoscopy procedures.
SCENARIA View Phase
FUJIFILM Corporation
Cardiology AI
FUJIFILM SCENARIA View Phase is an AI-powered CT system offering advanced imaging, significant dose reduction, and streamlined workflows for comprehensive diagnostic radiology, including cardiac and low-dose lung cancer screening.
Synapse 3D Base Tools
FUJIFILM Corporation
Radiology & Imaging AI
FUJIFILM Synapse 3D Base Tools is advanced medical imaging software offering comprehensive 2D, 3D, and 4D visualization, AI-powered segmentation, and image analysis for various modalities to enhance diagnostic workflows and treatment planning.

View company profile →

Suggest an Edit → | Last Verified: 2026-09-23 | First Added: 2026-09-23
AI Tool Finder
AI-powered search. Results may not be comprehensive.