RadioLens v1.0 by Synapsica is a medical image management and processing system that allows radiologists and medical practitioners to view, analyze, and report on DICOM-format radiology images. The software includes an AI module called SpindleX for automated analysis and measurement of spinal ligament injuries in digital stress X-rays of the cervical and lumbar spine. This helps clinicians by providing quantitative measurements and detailed reports, enhancing diagnostic accuracy and efficiency in spinal injury assessment.
Intended Use
RadioLens v1.0 software is a medical diagnostic application that displays, processes, stores, and transfers DICOM data except mammography. It provides image storage, patient data management, filtering, digital manipulation, and quantitative measurements. The optional SpindleX module aids analysis of vertebral displacements in spine using digital cervical and lumbar X-rays by semi-automatic anatomical identification and measurement to assist assessment of spinal ligament injury severity and location.
Technology
RadioLens v1.0 includes a cloud-based DICOM file transfer and browser interface for image viewing and reporting. The optional SpindleX module applies AI to digital stress X-rays of adult cervical and lumbar spine, automatically providing anatomical measurements such as vertebral offsets and angles. It uses a model trained on 20,000+ de-identified retrospective X-rays with radiologist-annotated ground truths. The software enables visualization, quantitative analysis, and report generation.
Performance
The device was clinically validated through a multi-reader, multi-center retrospective study of 600 stress X-rays from over 200 institutions, independent from the training data. Performance metrics showed high sensitivity for detecting body part and patient positioning (>90%), and measurement agreement between the AI model and expert radiologists was equivalent to that among radiologists themselves, with Intraclass Correlation Coefficients (ICC) mostly in the good to excellent range.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/21/2022
8 months - 2
FDA Approval
3/28/2023
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