FDA Clears Active Life’s OsteoProbe for Bone Material Strength Measurement
Active Life Scientific has secured FDA 510(k) clearance for OsteoProbe, the first device indicated to measure the Bone Material Strength index (BMSi). Designed for minimally invasive bone tissue assessment, OsteoProbe provides clinicians with a point-of-care method to evaluate bone quality as an adjunct to existing diagnostic tools.
Clinical evidence, including a National Institutes of Health (NIH)-funded study, showed that BMSi readings from OsteoProbe strongly correlate with whole bone strength at fracture-prone sites such as the hip, wrist, and spine. By integrating the device into routine care, clinicians can identify high-risk patients earlier, personalize treatment, and potentially reduce fracture incidence linked to osteoporosis.
Osteoporosis affects about 10 million people in the US, while another 44 million have low bone density, according to the Bone Health and Osteoporosis Foundation. The FDA also recently cleared Naitive’s OsteoSight, AI-powered software for BMD evaluation via standard X-rays.
03-10-2025
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