LARALAB
LARALAB GmbHLARALAB is an AI-powered medical imaging software that helps cardiologists, radiologists, and heart surgeons visualize, assess, and measure cardiovascular structures from medical images. It automates segmentation and measurements to assist in preprocedural planning and postprocedural review, improving workflow efficiency and accuracy in cardiovascular care.
Intended Use
LARALAB is a software application that provides cardiologists, radiologists, heart surgeons, and healthcare professionals additional information to aid in reading and interpreting DICOM-compliant medical images of heart and vessel structures. It enables visualization, assessment, and measurement for cardiovascular procedures, including preprocedural planning and postprocedural image review.
Technology
LARALAB is stand-alone cloud-based software that imports DICOM images and uses deterministic deep learning algorithms for automatic segmentation and measurements of cardiovascular structures. It allows manual adjustment, supports multiplanar reconstruction and surface rendering, and provides reporting tools.
Performance
Performance testing involved a 60-patient multi-centric study comparing LARALAB's automatic segmentation and measurement outputs to expert clinician ground truth using metrics such as Dice score, Bland-Altman analysis, and ICC. Results showed high accuracy and consistency comparable to the predicate device, meeting acceptance criteria with Dice scores of 0.89-0.98 and ICC values above 0.75.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/22/2024
7 months - 2
FDA Approval
4/16/2025
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