Medical AI specialist gains FDA clearance for new cardiothoracic imaging algorithm

Medical artificial intelligence specialist Imbio has received federal clearance for its new cardiothoracic imaging algorithm, the company announced late Tuesday.

The U.S. Food & Drug Administration 510(k) clearance applies to Imbio’s artificial intelligence-powered RV/LV Analysis tool.

In clinical practice, the algorithm quickly automates heart ventricle measurements to provide doctors with an accurate ratio of right- versus left-ventricle diameter. The RV/LV ratio, as it’s known, is crucial in predicting a patient’s risk for cardiovascular conditions such as pulmonary embolism.

"Our automated RV/LV Analysis has the power to provide vital information and inform risk stratification in many acute cases,” CEO of Imbio David Hannes said in an announcement. “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."

Such reporting is often done inconsistently or not at all, Hannes noted. And clinicians using this algorithm will have a robust report of quantitative findings within the patient’s imaging study within minutes, he added.

“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,” Jonathan Rodrigues, MD, a radiologist at Royal United Hospitals Bath NHS Foundation Trust, added March 16. “Used routinely, it has the potential to standardize risk stratification and augment clinical care in this important disease.”