MINNEAPOLIS, Minnesota—Imbio, LLC, a medical image processing software company, has received FDA 510(k) clearance for their Lung Density Analysis software application, developed in collaboration with medical researchers at the University of Michigan.
COPD (Chronic Obstructive Pulmonary Disease) is one of the leading causes of disability and death globally, affecting over 60 million people worldwide. COPD typically manifests as a mixture of lung tissue destruction (e.g. emphysema), and small airways disease (e.g. obstructive bronchitis). Imbio’s Lung Density Analysis software was created to help radiologists and pulmonologists better understand and quantify the components of COPD to potentially improve treatment and therapy planning.
“This groundbreaking technique reveals functional information about the lung’s performance that is not available through other means and will allow us to tailor more individualized treatment for these patients,” said Dr. Ella Kazerooni, Director of Cardiothoracic Radiology at the University of Michigan, and (current role at ACR). “We are very excited to see our technique launched as a commercial product, after years’ of development in our image processing lab and extensive clinical research in thousands of COPD patients.”
In combination with Imbio’s industry-leading IT platform, the Lung Density Analysis application completely automates this important new CT biomarker for COPD, providing results on the PACS alongside the original images, complementing the clinicians’ review.
Cynthia Maier, Chief Executive Officer of Imbio stated, “Imbio is proud to announce the first cleared application in our expanding portfolio of lung CT biomarkers. It is our core belief at Imbio that in order to be adopted into routine clinical care, biomarker analysis needs to be as transparent to clinicians as the math that creates the CT images in the first place. It is only the results of the analysis that are needed.”
Imbio will present their Lung Density Analysis at the annual meeting of the Radiological Society of North America (RSNA) taking place in Chicago, November 30th to December 4th, 2014. Imbio will be exhibiting at booth #3278 in the South Building, Hall A.
About Imbio, LLC Imbio, LLC, is a diagnostic, medical imaging software company founded to commercialize quantitative, unique imaging biomarkers developed by leading universities and research institutions. Imaging biomarkers are key drivers of personalized medicine which is expected to significantly improve outcomes and decrease healthcare costs. For more information, visit www.imbio.com.
Can Akgun, Ph.D.
Business Development Manager