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Imvaria, Inc.
Authorized purpose: Fibresolve analyzes lung CT in patients with pulmonary symptoms to provide an adjunct diagnostic-subtype classification for suspected interstitial lung disease and support referral to a multidisciplinary discussion.
Imvaria, Inc
Authorized purpose: ScreenDx provides adjunctive positive/negative assessment of interstitial lung findings on DICOM lung CT in patients older than 22 years to support referral for clinical assessment; it does not rule in or rule out lung fibrosis or replace standard diagnosis.
Imvaria, Inc
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). The device supplements the standardof-care workflow by providing a qualitative, diagnostic classification output of imaging findings based on machine learning pattern recognition, in order to provide adjunctive information as part of a referral pathway to an appropriate Multidisciplinary Discussion (MDD) or as part of an MDD. Specifically, the tool is used to serve as an adjunct in the diagnosis of idiopathic pulmonary fibrosis (IPF) prior to invasive testing. The results of Fibresolve are intended to be used only by clinicians qualified in the care of lung disease, specifically in caring for patients with ILD, in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment. The input to Fibresolve is a DICOM-compliant lung CT scan. Clinical case eligibility includes the following criteria: Age > 22 years old. Pulmonary symptoms suggestive of possible ILD including IPF.