ImageBiopsy Labs' Latest AI-Powered Software Granted FDA Clearance for Comprehensive Automated Measurements on Long Leg Radiographs

Saturday, June 24, 2023

ImageBiopsy Lab has recently received clearance from the United States Food and Drug Administration (FDA) for their latest software, IB Lab LAMA. This innovative software is the first of its kind, offering fully-automated radiological image processing for precise geometric length and angle measurements of the lower limb on full leg X-rays. Prior to this, ImageBiopsy Lab had already obtained FDA clearance for their IB Lab KOALA Knee-Osteoarthritis Labeling Assistant. With this recent achievement, the company plans to expand its presence in the US market by introducing additional software solutions focused on musculoskeletal (MSK) applications.

Every year, approximately two million joint replacements are performed worldwide, and this number is projected to double by the end of the decade. Accurate and standardized measurements of lower leg geometry are crucial in assessing patients before and after surgery. However, surgeons often face time constraints due to their heavy workload. Streamlining image-based workflows can free up valuable time for healthcare professionals to focus on proactive patient consultations and postoperative follow-ups.

IB Lab addresses this challenge by utilizing deep learning technology and advanced software engineering to expedite image-based workflows for both surgeons and radiologists. Their solution provides fast, accurate, and standardized radiological musculoskeletal (MSK) parameters on X-rays. These measurements are compared to predetermined norm-ranges based on established clinical practices. The results are summarized in detailed reports that can be easily viewed on authorized medical DICOM viewers.

The recent FDA clearance of IB Lab's LAMA module is a significant validation of the module's accuracy and quality. This milestone represents a major step forward in introducing AI-supported software tools to surgeons, not only to improve efficiency but also to enhance patient outcomes and follow-up care. Richard Ljuhar, CEO & co-founder of IB Lab, expressed the importance of providing surgeons with these advanced tools to benefit their patients.

Dr. Avneesh Chhabra, MD, MBA, FACR, Professor & Chief of the Musculoskeletal Radiology Division at the University of Texas Southwestern (UTSW) in Dallas and Principal Investigator of the Standalone Performance Study, acknowledged the significant potential of artificial intelligence in orthopedic surgery. By leveraging deep learning technology, the goal is to support pre- and post-operative decision management, ultimately leading to personalized treatment pathways for each individual patient.

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