ScreenDx
Imvaria, IncScreenDx is an AI-powered software device that analyzes lung CT scans to identify patterns suggestive of interstitial lung disease. It provides clinicians with a qualitative output to help refer patients who may benefit from further assessment of lung fibrosis, supplementing standard care workflows but not replacing diagnostic methods.
Intended Use
ScreenDx is a software-only device that receives and analyzes lung computed tomography (CT) imaging data to assess for interstitial lung findings compatible with interstitial lung disease. It provides a qualitative output based on pattern recognition to assist in referral pathways to clinicians qualified in lung disease care. It does not replace standard diagnostic methods and results are adjunctive.
Technology
ScreenDx consists of an image receiver API for image acquisition, an ingestion pipeline with a 3-D deep learning analysis algorithm that classifies lung CT scans based on pattern recognition of interstitial lung findings, and an output API that transmits notifications. It does not alter images or provide localization. The algorithm was trained on >3,000 cases from multiple clinical sites.
Performance
Performance was evaluated in a retrospective multi-center study of 3,018 unique CT cases with enriched positive rate of 23%. Sensitivity was 91.4%, specificity 95.2%, exceeding pre-specified goals. Additional validation in an independent dataset (n=2482) showed sensitivity 87% and specificity 98%. Performance was robust across demographics, smoking status, and CT technical settings.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/28/2024
6 months - 2
FDA Approval
1/10/2025
Other devices from Imvaria, Inc
- Fibresolve2024 • DE NOVO
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