The AI-powered tool automatically assesses medical data for interstitial lung findings compatible with interstitial lung disease. 


RT’s Three Key Takeaways:

  1. FDA Clears AI Tool for ILD Screening: Imvaria’s ScreenDx has received 510(k) clearance as an AI-powered tool to analyze CT imaging data and assist in identifying findings suggestive of interstitial lung disease (ILD).
  2. Support for Timely Diagnosis: ScreenDx is designed to supplement standard-of-care workflows, helping flag potential ILD cases earlier and reducing diagnostic delays through improved referral pathways.
  3. Imvaria’s Continued Focus on AI Solutions: The clearance of ScreenDx builds on Imvaria’s earlier FDA authorization for Fibresolve, an adjunctive diagnostic solution that uses AI to guide non-invasive diagnosis of idiopathic pulmonary fibrosis.

Imvaria Inc, a health tech company developing AI-driven digital biomarker solutions, announced its second US Food and Drug Administration (FDA) authorization, securing 510(k) clearance for its ScreenDx solution, an artificial intelligence (AI)-powered healthcare tool to assist clinicians in assessing for interstitial lung disease (ILD).

“ScreenDx is a software‐only device leveraging artificial intelligence to analyze CT imaging data for findings suggestive of interstitial lung disease,” says Joshua Reicher, MD, co-founder and CEO of Imvaria, in a release. “ScreenDx is designed to be supplementary for current standard-of‐care workflows, providing adjunctive information based on pattern recognition, as part of a referral pathway to an appropriate, qualified clinician.”

Patients with ILD often experience frequent diagnostic delays and often multiple clinical and radiological assessments before getting diagnosed. ScreenDx was developed by Imvaria to augment referral pathways by automatically assessing for interstitial lung findings compatible with interstitial lung disease, helping flag this disease in a range of settings. It is intended as an incidental screening tool to set patients on a path to be given an appropriate diagnosis and treatment on a timely basis.

“With the FDA 510(k) clearance of our ScreenDx digital solution, Imvaria continues on the quest to make AI highly practical, useful, and easy to incorporate into medical practice for the thousands of pulmonologists who treat patients with lung diseases,” says Michael Muelly, MD, co-founder and chief technology officer of Imvaria, in a release. “Our ultimate goal is to help patients with serious diseases, like ILD, get identified and placed into the diagnostic pathway as efficiently as possible, regardless of whether they were first seen in emergency, lung cancer screening, or specialty clinical settings. As medical doctors ourselves leading Imvaria, we are putting another powerful tool into the hands of clinicians to help enhance decision-making.”

This regulatory clearance builds on the company’s FDA authorization last year of Imvaria Fibresolve, an adjunctive diagnostic solution that uses AI to guide non-invasive diagnosis of idiopathic pulmonary fibrosis.

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