LVivo Software Application

The LVivo Software Application is a Class II medical device designed for the non-invasive, automated processing of ultrasound images, aiming to detect, measure, and calculate crucial medical parameters. It employs advanced algorithms to analyze echocardiographic examinations for ventricular function and also supports bladder volume measurement and contrast-enhanced image processing.

The LVivo Software Application, developed by DiA Imaging Analysis Ltd. and submitted by Medicsense USA LLC, has been officially classified as a Class II medical image management and processing system. Following review, this software was determined to be substantially equivalent to devices already on the market, affirming its suitability for continued marketing subject to general controls such as annual registration, device listing, good manufacturing practices, and proper labeling. The LVivo platform is specifically designed for the non-invasive processing of ultrasound images, serving to detect, measure, and calculate relevant medical parameters of patient structures and functions. Its comprehensive capabilities include automated analysis of echocardiographic examinations for both global and segmental left ventricular and right ventricular function, bladder volume measurement, and an advanced module for processing images acquired with contrast agents. Additionally, the system provides quality score feedback, enhancing the reliability of its analyses.

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 specific validation studies have been conducted to demonstrate the accuracy and reproducibility of LVivo's automated measurements compared to conventional manual methods?; How does the LVivo software's 'quality score feedback' mechanism function, and what impact does it have on inter-reader variability or diagnostic confidence?; Are there any clinical trials or real-world data available illustrating the impact of LVivo's use on clinical workflow efficiency or patient management decisions?; What are the specific technical requirements for ultrasound image acquisition (e.g., frame rate, resolution) to ensure optimal performance of the LVivo application for all indicated analyses?; Does the extended module for processing images acquired with contrast agents provide quantitative enhancement analysis, and how does it integrate with existing contrast agent protocols?