This article was originally published in The Gray Sheet
Executive SummaryDigital radiographic X-ray imaging device gains 510(k) clearance for in-office bone mineral density (BMD) testing. Intended for individuals at risk for osteoporosis and related bone fracture, the device scans the patient's fingers to estimate bone mineral density (BMD), which is used with a patient's T-score as an aid in assessing fracture risk. The clearance also covers monitoring of bone mass over time. The device uses "storage phosphor technology" in place of x-ray film as a radiation detection sensor
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