FDA Clears Imbio’s RV/LV Analysis Algorithm

March 16, 2021—Imbio, a provider of artificial intelligence solutions for medical imaging analysis, announced it has received FDA 510(k) clearance for a new algorithm intended to quickly and accurately measure the ventricles of the heart to provide the ratio of the maximum diameter of the right ventricle (RV) versus the left ventricle (LV), a key patient risk indicator for various pulmonary conditions such as pulmonary embolism.

According to the company, the RV/LV Analysis algorithm is a rapid, automated assessment of potential right ventricular dilation. The RV/LV Analysis results are automatically available for clinicians without any additional work and include a full report of quantitative findings added directly to the patient imaging study within minutes.

Imbio stated that quantitative evaluation of CT images can be used to aid clinicians in the risk stratification of pulmonary and cardiopulmonary diseases. For example, the imaging biomarkers for pulmonary embolism 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, noted the company.

“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,” commented Jonathan Rodrigues, MD, in the company’s announcement.

Dr. Rodrigues, who is a radiologist at the Royal United Hospitals Bath NHS Foundation Trust in Bath, United Kingdom, continued, “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.”