InVision Precision LVEF (LVEF)
InVision Medical Technology CorporationInVision Precision LVEF is a software tool that analyzes previously acquired transthoracic cardiac ultrasound images to automatically estimate the left ventricular ejection fraction, helping clinicians with cardiac evaluation. The software processes DICOM ultrasound videos, uses machine learning to segment the left ventricle, and allows clinicians to review and adjust the measurements for precise cardiac function assessment.
Intended Use
InVision Precision LVEF is used to process previously acquired transthoracic cardiac ultrasound images, store images, and manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system to provide an automated estimation of LVEF to assist clinicians in cardiac evaluation in patients 22 years and older.
Technology
This software operates on DICOM ultrasound video clips and uses a machine learning based algorithm to automatically select echocardiogram videos and perform semi-automatic segmentations of the left ventricle. It supports adjustable annotations and real-time update of ejection fraction calculations by clinicians. The user interface integrates with approved PACS systems.
Performance
Clinical performance was evaluated retrospectively on multicenter data including diverse patient populations and equipment. Metrics such as root mean square deviation for LVEF and Dice scores for segmentations demonstrated the software meets design criteria and is substantially equivalent to predicate device. Extensive verification and validation were performed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/4/2023
8 months - 2
FDA Approval
4/25/2024
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