COPD 3D Tracking Tool Granted 510k Status by FDA

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A 3-dimensional COPD identification and progression tracking technology has been granted 510k status by the US Food and Drug Administration.

The US Food and Drug Administration has granted 510(k) status to technology that analyzes lung density to detect chronic obstructive pulmonary disease (COPD).

In 2007, researchers from the University of Michigan developed parametric response mapping technology that is now utilized in a product called Lung Density Analysis (LDA), developed by Imbio. LDA can be sued to review images of patients’ lungs with detailed precision. The goal of the technology is to help doctors and physicians make more accurate diagnoses and develop better individualized treatments plans for each patient.

In 2012, lung imaging experts from the University of Michigan tested the technology and published the results in Nature Medicine.

“Essentially, with the parametric response mapping (PRM) technique, we’ve been able to tell sub-types of COPD apart, distinguishing functional small airway disease (fSAD) from emphysema and normal lung function,” senior author Brian Ross, PhD explained in a 2012 press release. “We believe this offers a new path to more precise diagnosis and treatment planning, and a useful tool for precisely assessing the impact of new medications and other treatments.”

The PRM system assigns colors to each small 3D area in the lung image based on differences in the signal changes within each area of scans, which are taken on a full exhalation and full inhalation. By creating a 3D map of the lungs, researchers and clinicians are able to identify healthy and diseased lung tissue. COPD progression can be tracked in this way, though spirometry is still the best option to diagnose COPD, noted the researchers in 2012.

“It’s incredibly gratifying to see this concept grow from an idea in our lab, to a product ready for market,” Ross explained in a 2014 news release. “We look forward to seeing how clinicians worldwide can use the LDA approach to benefit patients, and we’re grateful to all who have helped this concept reach this exciting point through many years of research and product development.”

Imbio presented its LDA technology at the recent annual meeting of the Radiological Society of North America (RSNA), held in Chicago from November 30 to December 4, 2014. Their new FDA status grants them the ability to explore launching the technology as a commercial product for pulmonologists and radiologists. The grant was based on the results of studies which included thousands of COPD patients, noted an Imbio statement.

“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,” explained lead clinical evaluator of the technology Ella Kazerooni, MD, chief of cardiothoracic imaging at the University of Michigan. “We are very excited to see the technique launched as a commercial product, after years of development in our image processing lab and extensive clinical research in thousands of COPD patients.”

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