Active Life Scientific, Inc. (ALSI), a leader in innovative medical devices for bone quality, today announced that the U.S. Food and Drug Administration (FDA) has granted a new 510(k) clearance (K250216) for OsteoProbe®, marking a historic milestone as the first device with an indication to measure the Bone Material Strength index (BMSi).
Current Osteoporosis diagnostic tools, like dual-energy X-ray absorptiometry (DXA), primarily measure bone mineral density (BMD), which explains only about 70% of bone strength variability. OsteoProbe® addresses this gap by using reference point microindentation (RPI) technology—a quick, office-based procedure performed on the mid-tibia—to quantify BMSi, revealing intrinsic bone material properties that BMD scans miss.