Active Life Scientific has gained 510(k) clearance from the US Food and Drug Administration (FDA) for OsteoProbe, a tool for minimally invasive bone tissue quality assessment.
OsteoProbe is claimed to be the first device to have received FDA approval for measuring the Bone Material Strength index (BMSi).
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According to Active Life and as evidenced in various trials, OsteoProbe “significantly” correlates with whole bone strength at the wrist, hip, and spine – common sites that are prone to bone fractures due to osteoporosis.
Indicated for use in adults to assess bone material strength as an adjunct to other diagnostic tools, OsteoProbe’s FDA clearance was supported by a National Institutes of Health (NIH)-funded study that demonstrated that BMSi measurements from OsteoProbe exhibit strong correlation with ex vivo whole bone strength testing across multiple skeletal sites.
Active Life’s founder Alexander Proctor commented: “This clearance represents a paradigm shift in how we evaluate and manage bone health.
“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, personalise treatment plans, and ultimately reduce the devastating impact of fractures.”
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By GlobalDataAccording to the Bone Health and Osteoporosis Foundation, around ten million patients in the US have osteoporosis while an estimated 44 million have low bone density, putting them at higher risk of developing the condition.
Earlier this month, the FDA cleared another tool to evaluate individuals’ risk of developing osteoporosis in the form of UK-based Naitive’s OsteoSight, an AI-powered software for bone mineral density (BMD) evaluation for the earlier identification of osteoporosis via standard X-rays.
