The FDA clearance follows after a phase II tralokinumab clinical trial published in the American Journal of Respiratory and Critical Care Medicine. Credit: Shutterstock / Gorodenkoff
UK-based artificial intelligence (AI) company, Brainomix, has seen its 360 e-Lung system granted market clearance from the US Food and Drug Administration (FDA) off the back of a study that found that AI devices are effective in detecting Idiopathic Pulmonary Fibrosis (IPF).
The Brainomix 360 e-Lung system is designed to recognise signs of Interstitial Lung Diseases (ILDs), a broad spectrum of more than 200 diseases, examining CT scans to quantify pulmonary fibrosis and other characteristics using proprietary imaging biomarkers.
The FDA clearance follows a phase II tralokinumab trial published in the American Journal of Respiratory and Critical Care Medicine that found the device was capable of identifying patients at risk of IPF progression, outperforming standard measures.
Run alongside AstraZeneca, the 52-week clinical trial of tralokinumab in patients with IPF set the groundwork for the company to move into the respiratory market after having previously found success Brainomix 360 platform for stroke care.
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.”
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Now, following successful market authorisation in both the US Brainomix says it aims to achieve market clearance in respiratory indications elsewhere.
It also follows after Brainomix teamed up with the Switzerland-based remote robotic surgical company Nanoflex Robotics with nearly $1m in financial backing from the UK and Switzerland to deliver an AI-assisted magnetic navigation system for robotic surgical tools.
Michalis Papadakis, CEO 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.”
