LVivo Seamless

LVivo Seamless is a specialized software application designed to automate the non-invasive analysis of cardiac ultrasound images, specifically for quantifying left ventricular Ejection Fraction. Its methodology involves offline processing of DICOM echo clips on a server, using its LVivo EF module to automatically select relevant frames, calculate EF via Simpson's method, and measure Global Longitudinal Strain, with results sent to PACS for clinical review.

LVivo Seamless, developed by DiA Imaging Analysis Ltd., is a standalone software application designed for the automated analysis of cardiac ultrasound (echocardiography) examinations. It operates offline on a server within a healthcare environment, accepting DICOM-formatted echo studies from ultrasound machines. The system's primary purpose is to automatically select appropriate cardiac image loops (clips) and then utilize its integrated LVivo EF module to perform an automated evaluation of left ventricular Ejection Fraction (EF). The processed results, including EF values, are then transmitted to a Picture Archiving and Communication System (PACS) for review and interpretation by healthcare professionals in the context of patients with suspected cardiac disease. The core methodology of LVivo Seamless for EF calculation relies on the automated identification of end-diastolic (ED) and end-systolic (ES) frames and subsequent left ventricular volume calculation using the standard Simpson's method of discs. A key characteristic of LVivo Seamless is its full automation post-clip selection, as it does not permit manual adjustments or editing of the ventricular contours by the user. While focused on EF, the system also provides Global Longitudinal Strain (GLS) measurement. However, it does not support segmental longitudinal strain, segmental wall motion evaluation, or volume curve presentation. The device is designed to work with DICOM clips from any vendor and includes automated rejection of false results, presenting EF for default cardiac beats.

AI Regulatory Concerns

Powered by

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What is the typical processing time for an individual patient study from DICOM ingestion to EF result availability in PACS using LVivo Seamless?; How does the "automated rejection of false results" feature function, and what are its performance metrics (sensitivity/specificity for rejecting poor quality studies or inaccurate analyses)?; Given the removal of manual adjustment capabilities, what validation studies were performed to ensure the accuracy and robustness of the fully automated EF and GLS calculations across diverse patient populations and image qualities?; How does the automated clip selection algorithm identify "adequate clips" for EF evaluation, and what criteria does it use?; What is the specific algorithm or method used by the LVivo EF module within Seamless to calculate Global Longitudinal Strain, especially in the absence of segmental strain analysis capabilities?