ImageBiopsy Lab has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its IB Lab Lama automated image processing software.
Designed to ease imaging workflows for surgeons and radiologists, the deep learning-based software analyzes geometric length and angle measurements of the lower limb on full-leg x-rays, according to the vendor. Measurements are compared to fixed predetermined norm ranges, based on standard clinical practices, and then the outputs are summarized in detailed reports that can be viewed on any cleared medical DICOM viewer, ImageBiopsy Lab said.
The Austrian company, which had previously received FDA clearance for its Knee-Osteoarthritis Labeling Assistant (KOALA) software said it aims to expand to the U.S. with further musculoskeletal-focused software applications.
