LVivo Software Application

The LVivo Software Application is a Class II medical device designed for the non-invasive, automated processing of ultrasound images to detect and measure medical parameters for diagnostic purposes. Its methodology involves digital image analysis and providing Quality Score feedback, with its efficacy and safety confirmed through performance evaluations and clinical validation, securing regulatory market authorization.

The LVivo Software Application, developed by DiA Imaging Analysis Ltd., has received marketing authorization as a Class II medical device. This application is designed for the non-invasive digital processing of ultrasound images to enable the automated detection, measurement, and calculation of various medical parameters related to anatomical structures and physiological functions in patients with suspected disease. A key feature includes the provision of Quality Score feedback to enhance the reliability of these analyses. The regulatory determination found the LVivo application, including its new LVivo PLAX module, to be substantially equivalent to existing medical devices, introducing no new safety or efficacy concerns. This conclusion was substantiated through rigorous performance evaluations and clinical validation studies, demonstrating the software's conformity to its intended use. Its continued availability in the market is contingent upon adherence to standard regulatory requirements such as annual registration, device listing, good manufacturing practices, and specific labeling guidelines.

AI Regulatory Concerns

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

• Q1. What specific medical parameters does the LVivo Software Application detect, measure, and calculate, and for which structures and functions in patients with suspected disease?; How is the 'Quality Score feedback' generated, what metrics does it use, and what impact does it have on the reliability or interpretability of the ultrasound image analysis results?; What were the specific methodologies, patient cohorts, and key outcomes of the 'performance evaluations and clinical validation' that demonstrated the LVivo application's conformity to its intended use and substantial equivalence?; Does the new LVivo PLAX module offer specific advantages over existing manual or automated methods for cardiac measurements, particularly regarding accuracy, reproducibility, or workflow efficiency?; What are the specific limitations, contraindications, or patient populations for which the LVivo Software Application is not recommended or has not yet been validated?