LVivo Seamless

The LVivo Seamless is a standalone medical image management and processing system designed to non-invasively automate the quantification of cardiac function, specifically Ejection Fraction and Global Longitudinal Strain, from DICOM-formatted ultrasound images. It achieves this by applying its proprietary analysis modules or integrating with cleared third-party software to streamline the assessment process for healthcare professionals.

On March 6, 2025, DiA Imaging Analysis Ltd. secured clearance for its medical device, LVivo Seamless, classified as a Medical Image Management and Processing System. This determination established its substantial equivalence to existing marketed devices for its specified uses, enabling its commercialization. The latest iteration of the device also features enhanced capabilities for automated EF and strain analysis via third-party software, a modification confirmed to maintain the device's safety and effectiveness following performance evaluations. LVivo Seamless operates as a standalone application, processing non-invasive ultrasound images offline on a server. It accepts ultrasound examinations in DICOM format to autonomously select relevant clips for the evaluation of Ejection Fraction (EF) and Global Longitudinal Strain (GLS). The system can activate its own analysis modules or integrate with other cleared third-party software for automated analysis, with all results subsequently transmitted to healthcare professionals for final review, while the company remains subject to ongoing regulatory obligations including quality system regulations, labeling, and adverse event reporting.

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 algorithms or AI models does LVivo Seamless utilize for automated EF and GLS analysis, and how do they perform across varying image qualities?; How does the integration with third-party software impact the validation and regulatory compliance of the overall analytical output, especially concerning data accuracy and security?; What are the typical clinical scenarios or patient populations where LVivo Seamless demonstrates the greatest benefit or highest diagnostic yield?; Does LVivo Seamless provide any quality metrics or confidence scores for its automated measurements, and how are these presented to clinicians for review?; What post-market surveillance plans are in place to assess the long-term clinical outcomes and real-world performance of LVivo Seamless in diverse clinical settings?