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# Brainomix Gets Clearance for AI e-Lung Tool
- URL: https://www.fdaweb.com/brainomix-gets-clearance-for-ai-e-lung-tool/
- Published: 2024-05-17T12:00:00.000Z
- Updated: 2026-09-14T14:31:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157013

FDA has cleared a Brainomix 510(k) for its Brainomix 360 [e-Lung](https://www.brainomix.com/ild/?ref=fdaweb.com) for lung imaging. The artificial intelligence-based workflow enhancement and visualization tool helps assess CT scans and thoracic datasets, providing automatic and objective quantifications of the lungs including lung segmentation, volumetric measurements, structural and coarse density evaluations, the company says.

The clearance is based on recent data from Brainomix that demonstrated e-Lung biomarkers’ capability to predict both short- and long-term outcomes in idiopathic pulmonary fibrosis (IPF) and non-IPF cohorts, including relative Forced Vital Capacity (FVC) decline and survival, the company says. “When compared to current standard measures, including FVC and radiological assessment, e-Lung biomarkers were a better predictor of survival when assessing change between two timepoints,” it says. “Brainomix's proprietary e-Lung biomarkers have been trained using thousands of CT scans from leading academic institutions to accurately quantify pulmonary fibrosis and other characteristics.”