LungMaps
Regulatory Status Disclosed
Overview
LungMaps by Siemens Healthineers is an AI-powered medical imaging tool designed for functional lung imaging using MRI. It aims to provide detailed visualization and quantification of ventilation and perfusion in the lungs without ionizing radiation or contrast agents.
- What it does: LungMaps generates ventilation-weighted and perfusion-weighted maps of the lungs. It also performs automatic parameter calculations, which are recorded in a report for longitudinal follow-ups. The technology is based on the Phase-Resolved Functional Lung (PREFUL) MRI method.
- Who it is for: This tool is intended for physicians managing patients with chronic pulmonary diseases such as Cystic Fibrosis (CF), Chronic Obstructive Pulmonary Disease (COPD), and Chronic Thromboembolic Pulmonary Hypertension (CTEPH). It is also indicated for monitoring and outcome prediction in lung transplant patients, including pediatric patients.
- How it fits a clinical or practice workflow: LungMaps integrates into existing MRI workflows, utilizing 2D MRI acquisition protocols. It is a post-processing application that relies on MRI data with sufficient temporal resolution to capture respiratory and cardiac signal variations. The generated reports support monitoring and adjustment of therapy decisions.
- Notable capabilities: A key capability is the ability to provide functional lung information without radiation burden, offering an alternative to nuclear medicine techniques for monitoring and outcome prediction. It offers detailed, comprehensive visualization of ventilation and perfusion, with automatic parameter calculation for consistent follow-up.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Free-breathing functional lung MRI without radiation burden
- Detailed comprehensive visualization of ventilation- and perfusion-weighted maps
- Automatic parameter calculation for longitudinal follow-ups
- Supports outcome prediction for lung transplants
- Supports monitoring in COPD, CF, and CTEPH
- AI-enabled analysis of lung imaging studies
- Improved diagnostic accuracy and workflow efficiency
Use Cases
- Functional lung imaging
- Monitoring therapy decisions for chronic pulmonary diseases (COPD, CF, CTEPH)
- Outcome prediction for lung transplants
- Assessing lung conditions through radiological image processing
- Reducing radiation burden for patients requiring repeated follow-up imaging
What Physicians Need to Know
DICOM Support & Standards
LungMaps, as a medical imaging application, inherently works with DICOM (Digital Imaging and Communications in Medicine) data. DICOM is the global standard for storing, transmitting, and managing medical imaging information. AI-powered DICOM analysis tools assist radiologists in identifying patterns, measuring abnormalities, and generating faster reports.
PACS Integration Method
LungMaps is a post-processing application that relies on MRI acquisition protocols. While specific integration methods for LungMaps aren't detailed, AI tools in radiology generally integrate with PACS (Picture Archiving and Communication Systems) to enhance workflow efficiency. This integration can involve packaging AI outputs as structured overlays, secondary captures, or structured reports using standard protocols like DICOM and HL7/FHIR. The goal is for AI-generated intelligence to appear within the radiologist's existing viewer, rather than requiring a separate application.
Reading Room Workflow Impact
LungMaps aims to be a paradigm shift for functional lung imaging by enabling MRI instead of nuclear medicine techniques, reducing radiation burden for patients. It provides automatic parameter calculation recorded in a report for longitudinal follow-ups. Generally, AI integration in radiology workflows can automate routine tasks, streamline reporting, and provide decision support, allowing radiologists to focus more on patient care and complex image analysis. AI can act as a second opinion, reducing diagnostic errors and improving efficiency.
AI Model Architecture (deep learning approach)
LungMaps is based on the PREFUL (Phase-resolved Functional Lung) method. It leverages advanced deep learning models for enhanced airway segmentation analysis and to estimate chronic perfusion defects from CT images. Deep learning, particularly convolutional neural networks (CNNs), is commonly used in lung imaging AI for tasks like identifying lung segments, detecting abnormalities, and image segmentation.
FDA Clearance Pathway (510k/De Novo)
LungQ, a related AI-enabled software platform for lung CT scans by Thirona, has received 510(k) clearance from the FDA for multiple versions, including LungQ 3.0.0 and LungQ 4. The 510(k) pathway is a premarket notification to demonstrate substantial equivalence to a legally marketed predicate device.
Supported Modalities (CT/MRI/X-ray/US)
LungMaps is specifically designed for functional lung imaging using MRI, enabling ventilation- and perfusion-weighted maps. It relies on 2D MRI acquisition protocols. While the core LungMaps application is MRI-focused, related AI tools for lung analysis can support other modalities like CT and X-ray.
Sensitivity & Specificity Data
For LungQ 4, a study comparing automated and manual assessments by expert bronchoscopists demonstrated excellent accuracy and reliability, with subcentimeter alignment between AI-identified pathways and expert-marked routes. This suggests AI is approaching expert-level performance in manual assessment for pre-procedural planning. For general AI in chest radiography, meta-analyses have shown pooled AI sensitivity of approximately 88% and specificity of 90% for pneumonia detection, and substantial gains in radiologist sensitivity (+~10%) for lung nodules with AI assistance. However, some studies indicate that radiologists can outperform AI in identifying lung diseases on chest X-rays in real-life scenarios, with AI tools sometimes producing more false-positive results.
RSNA/ACR Validation
While direct RSNA/ACR validation for LungMaps is not explicitly stated, the broader LungMAP project (Molecular Atlas of Lung Development Program) is a collaborative research program funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. This project aims to create a comprehensive map of the lung and provides open-access data and resources to the research community. The RSNA has also been involved in curating benchmark datasets for chest radiographs with AI-assisted expert labeling for validation of AI models.
Physician Tip
LungMaps offers a radiation-free alternative to nuclear medicine for functional lung imaging, which is particularly beneficial for patients requiring constant surveillance, such as those with Cystic Fibrosis, COPD, or CTEPH. The detailed visualization of ventilation- and perfusion-weighted maps and automatic parameter calculation can aid in monitoring therapy decisions and predicting outcomes. While AI tools like LungMaps enhance diagnostic capabilities and workflow, the radiologist's expertise remains paramount for final diagnosis and complex case interpretation.
Seamless integration of AI tools like LungMaps into existing PACS and RIS is crucial for maximizing their benefits in the reading room. This means AI-generated insights should appear directly within the radiologist's primary workflow, avoiding the need for multiple logins or separate applications. Adherence to DICOM standards is fundamental for data exchange, and integration should leverage existing protocols like HL7/FHIR for clinical context and structured reporting.
Details
| Category | Radiology & Imaging AI |
| Pricing | Unknown — unknown |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Cleared AI-estimated LungMaps is an automated software developed by Siemens Healthineers that received FDA 510(k) clearance on June 15, 2026. It is designed to assist clinicians in analyzing lung imaging studies, helping to detect and assess lung conditions by processing radiological images to improve diagnostic accuracy and workflow efficiency. |
| Integrations | |
| EHR | Not specified |
| Specialties | Critical Care, Pulmonology, Radiology |
What the Web Says
LungMaps, also referred to as Lung-MAP and LungMAP.net, is a comprehensive platform designed for lung research and clinical trials, integrating multi-omics data, computational tools, and a cloud computing environment. It aims to enhance molecular biological education and research for the lung, providing a central resource for hypothesis-driven research and exploratory investigations. The platform is also used in clinical settings to evaluate biomarker-driven therapies and immunotherapies in non-small cell lung cancer.
Overall: MixedStrengths
- Integrates comprehensive multi-omics, multi-technology, and multi-species information for lung research.
- Utilizes a cloud computing platform for integrative analysis, accessible to physicians and biologists without extensive prior experience.
- Aggregates data from various research networks, promoting broader scientific community participation and collaboration.
- Supports hypothesis-driven research questions and broad exploratory investigations, breaking down data silos.
- Provides a web portal for presentation of results and public sharing of data sets, including high-resolution lung images and molecular data.
- Offers advanced tools for diagnosing lung diseases like pulmonary embolism and emphysema by turning CT scans into detailed lung maps.
Limitations
- One potential area for future improvement is the collection of spatial transcriptomics data for lung diseases.
- 4DMedical, which offers CT:VQ software for lung maps, is currently loss-making and has negative share price performance, indicating a high-risk investment.
- Some reviews for general software review platforms (like Capterra and G2, where LungMaps reviews might appear) mention concerns about biased or promotional reviews and slow review publishing processes.
Based on reviews from: Yale Medicine (Clinical Trials), Oxford Academic (American Journal of Respiratory Cell and Molecular Biology), PMC - NIH (National Library of Medicine), YouTube (RCMB Toolkit), G2, TrustRadius, PubMed - NIH (National Library of Medicine), Capterra, Quora, Indeed.com, Motley Fool
Last updated: 2026-09-26
Ratings & Reviews
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Press & Coverage
Innolitics
Q2 2026 AI/ML FDA Clearances and De Novos - Innolitics
LungMaps, developed by Siemens Healthineers, received 510(k) FDA clearance on June 15, 2026, for its AI/ML-powered software that assists radiologists in diagnosing lung function by segmenting 2D lung MR time series and generating perfusion/ventilation maps and statistics. This was part of 86 AI/ML devices authorized by the FDA in Q2 2026.
2026-07
Siemens Healthineers
LungMaps - Siemens Healthineers
LungMaps is a Siemens Healthineers application that provides radiation-free, functional lung imaging using MRI to generate perfusion- and ventilation-weighted maps, aiding in monitoring and outcome prediction for chronic pulmonary diseases. It aims to shift functional lung imaging away from nuclear medicine techniques.
unknown
FDA
K253690 - 510(k) Premarket Notification - FDA
This regulatory announcement details the 510(k) Premarket Notification for LungMaps, submitted by Siemens Healthineers AG, which received clearance on June 15, 2026. The product is classified under Radiology with product code QIH.
2026-06
FDA
List of Artificial Intelligence-Enabled Medical Devices - FDA
LungMaps by Siemens Healthineers AG is listed as an AI-enabled medical device authorized for marketing in the United States, with a clearance date of June 15, 2026. This list provides transparency for healthcare providers and patients regarding AI technologies in medical devices.
2026-09
Siemens Healthineers (MAGNETOM World)
LungMaps Protocols for MAGNETOM Scanners
This article provides technical protocols for using LungMaps with MAGNETOM MRI scanners, emphasizing its ability to provide functional lung information without radiation, based on the PREFUL method. It highlights the importance of assessing lung function in chronic pulmonary diseases.
unknown
Siemens Healthineers
Innovation Highlights 2026 - Siemens Healthineers
Siemens Healthineers highlights LungMaps as a key innovation for 2026, positioning it as a paradigm shift in functional lung imaging by utilizing MRI to reduce radiation burden for patients and improve therapy monitoring and outcome prediction.
2026
ReachMD
AI Diagnostic Benchmark Hub - ReachMD
LungMaps from Siemens Healthineers AG is featured in the Medical AI Diagnostic Benchmark Hub, a specialty-filtered database of FDA-cleared AI diagnostic devices. It notes the FDA clearance (K253690) and its application in Radiology.
2026
FDA
TPLC - Total Product Life Cycle - FDA
The FDA's Total Product Life Cycle database shows LungMaps (K253690) by Siemens Medical Solutions U.S.A. as substantially equivalent, indicating its clearance for marketing. The product falls under medical image management and processing systems utilizing AI.
2026-09
Videos
Product demos, reviews, and walkthroughs for LungMaps.
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Frequently Asked Questions
LungMaps is an AI-powered radiology imaging solution designed to assist in the analysis of lung imaging. It integrates with existing Picture Archiving and Communication Systems (PACS) and Electronic Medical Record (EMR) systems through standard protocols like DICOM and HL7, aiming for a seamless workflow within your current infrastructure.
LungMaps is built with robust security features and protocols to ensure compliance with HIPAA and other healthcare data privacy regulations. Data is de-identified and encrypted during transfer and processing, and access controls are strictly managed to protect patient information.
LungMaps provides key performance metrics such as sensitivity, specificity, and accuracy for various lung pathologies, which are detailed in its technical documentation. While highly effective, its limitations include potential variations in performance based on image quality, rare disease presentations, and the need for ongoing human oversight and interpretation.
Yes, there are other AI solutions in the market for lung imaging analysis. LungMaps differentiates itself through its proprietary algorithms, specific focus on a comprehensive range of lung pathologies, and its user-friendly interface designed for seamless integration into existing radiology workflows.
The pricing structure for LungMaps typically involves a subscription model, with different tiers available based on usage volume, features, and integration requirements. Specific pricing details and available models can be obtained by contacting our sales department for a customized quote.
LungMaps is primarily focused on lung pathologies, but it is designed to flag potential incidental findings that may warrant further review by a radiologist. It will highlight areas of interest that fall outside its primary analytical scope, prompting the physician for a comprehensive assessment.
Comprehensive training and support are provided for both physicians and technical staff. This includes onboarding sessions, user manuals, online tutorials, and dedicated technical support to ensure effective utilization and troubleshooting of LungMaps within your clinical environment.
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| Last Verified: 2026-09-23 | First Added: 2026-09-23