Brainomix Receives FDA Clearance of e-Lung AI Software

Brainomix, a pioneer in artificial intelligence (AI) imaging solutions to enable precision medicine, has gained FDA clearance for its Brainomix 360 e-Lung. 
 
This marks Brainomix’s entry into the lung imaging space, following a series of clearances and widespread clinical adoption of its Brainomix 360 Stroke platform in the US and Europe. Brainomix aims to expand its footprint in medical imaging beyond stroke-related applications and work towards advancing lung imaging solutions.
 
Dr Michalis Papadakis, CEO and Co-Founder of Brainomix, said: “We are harnessing our expertise in AI-powered imaging to develop novel biomarkers in other disease indications where AI can support imaging-based diagnostic and treatment decisions. This e-Lung FDA clearance reflects our focus on developing innovative solutions that empower healthcare professionals with cutting-edge tools for sophisticated disease evaluation, enhancing access to treatments that can ultimately work to improve patient outcomes.”
 
Brainomix recently published a new study [1] in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). The results showed that Brainomix’s proprietary lung imaging biomarkers, which include the weighted reticulovascular score (WRVS), stratified patients at risk of Idiopathic Pulmonary Fibrosis (IPF) progression, outperforming standard measures.
 
Dr Deji Adegunsoye, Assistant Professor of Medicine and Scientific Director of the Interstitial Lung Disease Program at the University of Chicago Medicine, said: “This is an exciting step for Brainomix, who have a demonstrated track record of developing novel AI-based solutions in stroke and are now applying that expertise to develop innovative tools in the lung space. The preliminary data for e-Lung is impressive and would indicate that we have a promising tool that could help to expedite healthcare delivery and improve clinically meaningful outcomes for patients with lung disease.”

Resources: 

1. Am. J. Respir. Crit. Care Med.: 2024 Feb 16 – e-Lung CT Biomarker Stratifies Patients at Risk of IPF Progression in a 52-Week Clinical Trial