June 26, 2023

ImageBiopsy Lab (IB Lab) expands its FDA-cleared musculoskeletal (MSK)-portfolio with the 510(k) clearance of its LAMA software.

Vienna, Austria — ImageBiopsy Lab announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for IB Lab LAMA, the first fully-automated radiological image processing software for geometric length and angle measurements of the lower limb on full leg X-rays. The company previously FDA-cleared its IB Lab KOALA Knee-Osteoarthritis Labeling Assistant and intends to expand to the US with further MSK-focused software solutions.

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ImageBiopsy Lab (IB Lab) expands its FDA-cleared musculoskeletal (MSK)-portfolio with the 510(k) clearance of its LAMA software.

Vienna, Austria — ImageBiopsy Lab announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for IB Lab LAMA, the first fully-automated radiological image processing software for geometric length and angle measurements of the lower limb on full leg X-rays. The company previously FDA-cleared its IB Lab KOALA Knee-Osteoarthritis Labeling Assistant and intends to expand to the US with further MSK-focused software solutions.

June 26, 2023

Nearly two million joints are replaced every year worldwide and that number is set to double by the end of the decade. Accurate and standardized measurements to assess the lower leg geometry are critical before and after surgery. However, orthopedic surgeons are often time constrained due to large caseloads and busy practices. Relieving healthcare professionals of time-consuming and repetitive tasks frees up valuable time for proactive patient consultations and postoperative follow ups.

Reliable. Fast. Cost Efficient.

IB Lab expedites and standardizes image-based workflows of surgeons and radiologists alike by combining deep learning technology and state of the art software engineering to provide fast, accurate and standardized radiological MSK parameters on plain film X-rays. The measurements are compared to fixed predetermined norm-ranges, based on standard state of the art clinical practices. Outputs are summarized in detailed reports that can be viewed on any cleared medical DICOM viewer.

With this achievement, IB Lab aims to aid healthcare professionals to provide the highest standard of care. Today’s announcement means IB Lab has cleared the last major hurdle before it can start making its solution widely available to surgeons and healthcare providers in the United States.

“This FDA clearance serves as a significant validation of the accuracy and quality of our LAMA module. It is a huge milestone for our company to bring cutting-edge, AI-supported software tools to surgeons, not only to make their work easier and more efficient, but also to improve the outcomes and follow-ups for their patients” said Richard Ljuhar, CEO & co-founder of IB Lab. 

“The deep learning technology underlying IB Lab LAMA helps drive potential improvement in orthopedic workflow. We’re thrilled the 510(k) approval now allows us to fully unlock our US commercialization strategy to achieve positive outcomes for more patients,” Christoph Götz, Chief Operating Officer and Executive Management Team member.

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 LAMA Standalone Performance Study at UTSW:

“Artificial intelligence’s potential role in orthopedic surgery is significant. Using deep learning, we aim to support pre- & post-operative decision management, representing a potential key for a more personalized treatment pathway for each patient”

ImageBiopsy Lab develops award-winning AI-driven solutions that digitize musculoskeletal (MSK) diagnostics on radiographs, providing radiologists and orthopedics with fast, quantitative, and standardized reports of disease-relevant findings and measurements. The company portfolio already includes solutions for knee, hip, hand, leg and spine. Additionally, ImageBiopsy Lab now offers fracture detection, further enhancing their comprehensive range of solutions.

References

https://www.prnewswire.com/news-releases/fda-clears-imagebiopsy-labs-latest-ai-powered-software-for-a-comprehensive-set-of-automated-measurements-on-long-leg-radiographs-301860985.html