Imbio receives FDA 510(k) clearance for cardiothoracic imaging algorithm

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Imbio has received US Food and Drug Administration (FDA) 510(k) clearance for its RV/LV Analysis algorithm.

The RV/LV Analysis algorithm is a rapid, automated assessment of potential right ventricular dilation. The tool measures the ventricles of the heart to provide the ratio of the maximum diameter of the right versus the left ventricle. The resulting RV/LV ratio is a key patient risk indicator for various pulmonary conditions such as pulmonary embolism (PE). RV/LV Analysis results are automatically available for clinicians without any additional work including  a full report of quantitative findings added directly to the patient imaging study within minutes.

“Imbio is proud to deliver this AI-driven algorithm to clinicians and our partners to support acute cases and assist in key treatment decisions for patients,” said David Hannes, Imbio Chief Executive Officer. “Our automated RV/LV Analysis has the power to provide vital information and inform risk stratification in many acute cases. We believe that the routine use of the RV/LV Analysis in clinical practice can also enable more consistent, quantitative reporting of potential right heart strain for all CTPA exams.”

Quantitative evaluation of computed tomography (CT) images can be used to aid clinicians in the risk stratification of pulmonary and cardiopulmonary diseases. The imaging biomarkers for PE, for example, can be measured reliably and consistently for real-world use-cases. Additionally, varying causes of right ventricular dilatation may be captured earlier if RV/LV automation is routinely implemented within native clinical workflows. With the ability to run the automated analysis and have results available at the time of the initial clinical reading, it may potentially save reporting time as well.

“Reporting right heart strain on CT pulmonary angiogram studies positive for pulmonary embolism, despite what we are inclined to think, is frequently done inconsistently, incorrectly or not at all. We have shown Imbio’s RV/LV Analysis to work consistently in unselected real-world cases and have demonstrated how it could alter management, as well as potentially predict all-cause mortality. Used routinely, it has the potential to standardize risk stratification and augment clinical care in this important disease,” said Jonathan Rodrigues, Radiologist at Royal United Hospitals Bath NHS Foundation Trust.


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