Lung Density Analysis - Functional

Imbio
Lung Density Analysis™ applies big data analysis to paired inspiratory / expiratory chest CT studies to provide visualization and quantification of lung regions with abnormal tissue density. Functional LDA is an automated image analysis providing a mapping of normal lung, air-trapping and areas of persistent low density (< -950 HU, which may be indicative of emphysema in a combined image to help visualize the components of COPD. LDA provides a full 3D DICOM series with density overlays and a quantitative report of density categories by lung region.
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Information source: Vendor
Last updated: February 25, 2024

General Information

General
Product name Lung Density Analysis - Functional
Company Imbio
Subspeciality Chest
Modality CT
Disease targeted COPD, emphysema, asthma, BOS
Key-features Lung density quantification, abnormal lung region mapping, report generation
Suggested use Before: stratifying reading process (non, single, double read), adapting worklist order, flagging acute findings
During: perception aid (prompting all abnormalities/results/heatmaps), interactive decision support (shows abnormalities/results only on demand), report suggestion
After: diagnosis verification
Without interference of a radiologist: AI-only diagnosis

Technical Specifications

Data characteristics
Population COPD patients, cases of suspected BOS or asthma
Input HRCT
Input format DICOM
Output Report in PDF or DICOM, overlays
Output format DICOM, PDF, CSV
Technology
Integration Integration in standard reading environment (PACS), Integration via AI marketplace or distribution platform, Stand-alone third party application, Stand-alone webbased
Deployment Locally virtualized (virtual machine, docker), Cloud-based
Trigger for analysis Automatically, right after the image acquisition, On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time > 10 minutes

Regulatory

Certification
CE
Certified, Class IIa , MDD
FDA 510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE)

Market

Market presence
On market since 2015
Distribution channels Nuance PIN, Eureka Clinical AI, syngo.via, Wellbeing Software, Aidoc aiOS, Blackford
Countries present (clinical, non-research use) >20
Paying clinical customers (institutes) >20
Research/test users (institutes) >20
Pricing
Pricing model Pay-per-use, Subscription
Based on Number of installations, Number of analyses

Evidence

Evidence
Peer reviewed papers on performance
Non-peer reviewed papers on performance
Other relevant papers

  • Quantitative Emphysema on Low-Dose CT Imaging of the Chest and Risk of Lung Cancer and Airflow Obstruction: An Analysis of the National Lung Screening Trial (read)