InVision receives U.S. FDA Clearance for Precision LVEF

InVision Medical Technology Corporation (“InVision”), a medical AI company backed by Y Combinator, has received U.S. Food and Drug Administration (FDA) clearance for Precision Left Ventricular Ejection Fraction (LVEF) for automated evaluation of LVEF.  

InVision Precision LVEF is advanced image post-processing analysis software designed to aid diagnostic review, analysis, and reporting of echocardiographic DICOM images for cardiac function. Building upon some of the first video AI models for echocardiography¹, InVision Precision LVEF is the only AI-Echo product that has undergone blinded, randomized prospective clinical trial evaluation². This clinical trial has shown thatInVision Precision streamlines the echocardiographic workflow with time savings and improves clinical precision in assessing LVEF.

InVision Precision LVEF is trained with the most training videos compared to all existing FDA-cleared echocardiography AI models and is the only AI-Echo device shown to be preferred by cardiologists in blinded, randomized testing². “Not all AI devices are the same, with many examples in the AI literature to show model performance correlates with the number of training examples. We are proud of the rigorous development and testing process that InVision Precision LVEF has undergone,” said Bryan He, PhD, co-founder of InVision. “AI has the potential to improve access to and quality of care and may allow for timely detection of heart failure.”

“Accurateassessment of heart function is critical for the diagnosis and treatment of many cardiovascular diseases. By offering advanced capabilities to assess heart function more precisely, we hope such technology can improve clinical care in critical junctures such as in heart failure, cardio-oncology, and cardiomyopathy disease settings³,” said David Ouyang, MD, co-founder of InVision.  “We feel strongly that excellent clinical care should be available to every patient and hope to make such technologies available to all clinicians in all clinical settings.”

InVision Precision is intended for use in adult patients and supports qualified medical professionals in clinical decision-making. A demo is available at https://demo.invisionmedtech.com/. The waitlist to sign up is at https://invisionmedtech.com/precision-lvef/.

1.     Ouyang, D. et al. Video-based AI for beat-to-beat assessment of cardiac function. Nature 580, 252–256 (2020).

2.     He, B. et al. Blinded, randomized trial of sonographer versus AI cardiac function assessment. Nature 616, 520–524 (2023).

3.     Pillai, B., Salerno, M., Schnittger, I., Cheng, S. & Ouyang, D. Precision of echocardiographic measurements. J. Am. Soc. Echocardiogr. (2024) doi:10.1016/j.echo.2024.01.001.