Company Spotlight: Imvaria Fibresolve - AI for Lung Fibrosis with a Built-In Update Plan

We unpack the FDA 510(k) summary for Imvaria's Fibresolve with PCCP. This software-only device analyzes lung CT scans as an adjunct for diagnosing idiopathic pulmonary fibrosis prior to invasive testing. We explore how its Predetermined Change Control Plan allows the manufacturer to update and re-train the AI model over time without requiring new regulatory clearance.

Key points

• Fibresolve is a Class II software-only device that uses an ensemble 3D deep learning model to analyze DICOM-compliant lung CT scans for suspected interstitial lung disease.
• It acts as an adjunct in the diagnosis of idiopathic pulmonary fibrosis (IPF) prior to invasive testing, specifically for patients strictly > 22 years old.
• The clearance is based on substantial equivalence to the original Fibresolve (DEN220040), but the summary notably does not provide specific clinical dataset sizes or performance metrics.
• The clearance includes a Predetermined Change Control Plan (PCCP), allowing Imvaria to modify model architecture, introduce new training data, and incorporate ancillary inputs like age, sex, and pulmonary function tests without submitting a new 510(k).

Source: FDA 510(k) summary K252041: Fibresolve (with PCCP) (Imvaria) - U.S. Food and Drug Administration, 2025

This episode is an AI-generated conversation summarising a public document; the hosts' voices are synthetic. It is for information only and is not medical advice. Always refer to the original source.

Company: Imvaria (imvaria.com) · Product: Fibresolve (with PCCP) · FDA 510(k) K252041

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/company-spotlight-imvaria-fibresolve-ai-for-lung-fibrosis-with-a-built-ea3e45