ImageBiopsy Lab has received approval from the US Food and Drug Administration (FDA) for its fully automated radiological image processing software, IB Lab LAMA.
The artificial intelligence (AI)-powered software is intended for the lower limb’s geometric length and angle measurements on full-leg X-rays.
Earlier, the company secured approval from the FDA for its IB Lab KOALA Knee-Osteoarthritis Labeling Assistant. It aims to expand to the US with more musculoskeletal (MSK)-focused software solutions.
IB Lab CEO and co-founder Richard Ljuhar said: “FDA clearance serves as a significant validation of the accuracy and quality of our LAMA module.
“It is a huge milestone to bring AI-supported software tools to surgeons, not only to increase efficiency but also to improve the outcomes and follow-ups for their patients.”
The company combines deep learning technology and advanced software engineering to deliver precise, rapid, standardised radiological MSK parameters on X-rays, helping surgeons and radiologists expedite image-based workflows.
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Based on standard clinical practices, the measurements are compared to fixed predetermined norm ranges.
Detailed reports summarising the outputs can be accessed through any cleared medical DICOM viewer.
ImageBiopsy Lab is involved in the development of AI-driven solutions to digitise MSK diagnostics on radiographs.
University of Texas Southwestern (UTSW) in Dallas musculoskeletal radiology professor and chief Avneesh Chhabra said: “Artificial intelligence’s potential role in orthopaedic surgery is significant.
“Using deep learning, we aim to support pre and post-operative decision management, representing a potential key for a more personalised treatment pathway for each patient.”