Oxford healthtech Brainomix gets FDA clearance for e-Lung AI software

Brainomix, a pioneer in AI imaging solutions to enable precision medicine, has secured clearance from the US Food and Drug Administration (FDA) for its latest product, the 360 e-Lung.

The Oxford firm’s entry into the lung imaging space follows a series of successful clearances and widespread clinical adoption of its Brainomix 360 Stroke platform in both the US and Europe.

The company plans to expand its research collaborations in the pulmonology space to inform future iterations of e-Lung and continue to improve its lung imaging technology.

Dr Deji Adegunsoye, assistant professor of medicine and scientific director of the Interstitial Lung Disease Program at 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.”

Brainomix recently announced the publication of a new study in the American Journal of Respiratory and Critical Care Medicine (AJRCCM), resulting from a research collaboration with AstraZeneca.

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 Michalis Papadakis, CEO and co-founder of Brainomix, added: “We’re 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 will be presenting its latest e-Lung data at the American Thoracic Society (ATS) annual conference in San Diego from 17 to 22 May, including results from research collaborations with Heidelberg University and Seattle-based Avalyn Pharma.