UK-based artificial intelligence (AI) company Brainomix got FDA approval for its latest product, the 360 e-Lung system, after successfully completing its phase II trial.

The Brainomix 360 e-Lung system is designed to identify interstitial lung diseases (ILDs), which are more than 200 diseases. It examines CT scans to quantify pulmonary fibrosis and other features using proprietary imaging biomarkers.

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Phase II Trial Validates Brainomix 360 e-Lung Superiority 

The FDA clearance is based on a phase II tralokinumab trial that found the device outperformed standard measures in identifying patients at risk of IPF progression. Dr. Deji Adegunsoye, scientific director of the ILD program at the University of Chicago Medicine, said,

“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.”

A study published in Frontiers in Neurology, which aligns with previous research, reported significant improvements in patient outcomes at the Royal Berkshire Hospital after using Brainomix 360 Stroke. The percentage of stroke patients achieving functional independence tripled from 16% to 48%. 

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Brainomix Expands Reach Through Strategic Partnerships

Early this year, Brainomix teamed up with Nanoflex Robotics, a Switzerland-based remote robotic surgical company. This partnership, which has nearly $1m in financial backing from the UK and Switzerland, will deliver an AI-assisted magnetic navigation system for robotic surgical tools.

“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.”

Dr Michalis Papadakis, CEO and co-founder of Brainomix

Additionally, Brainomix collaborated with AstraZeneca on the latter’s Phase 2 clinical trial of the drug Tralokinumab to treat the lung condition Idiopathic Pulmonary Fibrosis (IPF). Data published in the American Journal of Respiratory and Critical Care Medicine showed that Brainomix’s e-Lung AI-enabled software could help differentiate patients in trials most at risk of decline and outperform current standard measures.

Cryptopolitan reporting by Brenda Kanana