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 imaging algorithm receive fda 510


Imbio's New Cardiothoracic Imaging Algorithm Receives FDA 510(k) Approval

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Imbio has gained FDA 510(k) clearance for its RV/LV AnalysisTM algorithm, a leading supplier of artificial intelligence (AI) solutions for medical imaging evaluation. The RV/LV Analysis algorithm is a quick and easy way to check for right ventricular dilation. The tool efficiently and precisely evaluates the heart's ventricles to calculate the proportion of the right to left ventricle's maximum diameter. The RV/LV Analysis results are readily accessible for clinicians without any extra work, including a detailed report of quantitative findings directly attached to the patient imaging study in minutes. David Hannes, Imbio Chief Executive Officer, stated that their automated RV/LV Assessment has the control to supply factual information and notify risk stratification in many acute cases. Imbio is proud to offer this AI-driven algorithm to physicians and partners to support acute cases and facilitate critical treatment decisions for patients.