Active Life Scientific, a company specializing in medical devices for bone quality, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for OsteoProbe with an indication to measure the Bone Material Strength index (BMSi).

The novel metric is called BoneScore commercially. The metric provides a direct, minimally invasive assessment of bone tissue quality, correlating with whole bone strength at critical fracture sites (hip, wrist, and spine) as well as traditional mechanical properties like fracture toughness.

Current diagnostic tools like dual-energy X-ray absorptiometry (DXA) mainly measure bone mineral density (BMD), which explains about 70% of bone strength variability. OsteoProbe uses reference point microindentation (RPI) technology—a quick, office-based procedure performed on the mid-tibia—to quantify BMSi. This reveals intrinsic bone material properties that BMD scans miss, the company said.

The FDA nod was based on an NIH funded Phase II Small Business Innovation & Research grant that showed BMSi measurements from OsteoProbe demonstrate strong correlations with ex vivo whole bones strength testing across multiple skeletal sites, including hip and spine models. It also aligned with established metrics like fracture toughness and post-yield deformation.

The device is indicated for adults to assess bone material strength as an adjunct to other diagnostic tools.

“This clearance represents a paradigm shift in how we evaluate and manage bone health,” said Alexander Proctor, founder of Active Life Scientific. “For the first time, clinicians can measure bone strength in a simple, point-of-care setting, providing actionable data that correlates strongly with bone strength at the hip, wrist, and spine. By integrating OsteoProbe into routine assessments, we hope to identify at-risk patients earlier, personalize treatment plans, and ultimately reduce the devastating impact of fractures.”

The expanded indication builds on the company’s foundational de novo classification, which established it as the first FDA-cleared microindentation device for bone tissue assessment. The handheld system was designed for use in outpatient settings, requires minimal training, and generates results in under five minutes.