Fibresolve
Imvaria, IncFibresolve is a software device that analyzes lung CT images using deep learning to identify patterns suggestive of idiopathic pulmonary fibrosis. It provides a binary output to assist clinicians in diagnosing fibrotic lung disease, serving as an adjunct tool in the diagnostic workflow especially before invasive testing, helping to improve early detection and referral for appropriate clinical discussion.
Intended Use
Fibresolve is a software-only device that receives and analyzes lung computed tomography (CT) imaging data in order to provide a diagnostic subtype classification in suspected cases of interstitial lung disease (ILD). It is used as adjunctive information as part of a referral pathway to an appropriate Multidisciplinary Discussion (MDD) or as part of an MDD, and specifically serves as an adjunct in diagnosis of idiopathic pulmonary fibrosis (IPF) prior to invasive testing.
Technology
Fibresolve is a Software as a Medical Device (SaMD) that uses a 3D deep learning algorithm to assess DICOM-compliant lung CT images for patterns consistent with idiopathic pulmonary fibrosis among interstitial lung disease cases. It operates via cloud APIs that receive CT images, perform processing and analysis, and output a binary classification report indicating 'Suggestive of IPF' or 'Inconclusive'. It does not perform image segmentation or provide visual image interpretation aids.
Performance
Clinical performance testing involved 300 ILD cases with CT images mostly ≤3mm slice thickness. Device sensitivity for IPF detection was 55% and specificity was 82%, compared to expert panel sensitivity 20% and specificity 95%. The software generated a higher true positive rate but also higher false positives, emphasizing the need for multidisciplinary review to mitigate risks. Postmarket data collection is required to refine performance estimates.
Device Timeline
- 1
Submission
6/29/2022
1 year, 6 months - 2
FDA Approval
1/12/2024
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