OsteoSight Gets FDA Breakthrough Device Designation for Bone Mineral Density Assessment on X-Rays
By leveraging subtle signals on routine X-rays to assess bone mineral density (BMD), the technology may facilitate earlier detection of osteoporosis and help prevent fragility fractures.
The Food and Drug Administration (FDA) has granted a breakthrough device designation for OsteoSight, which reportedly provides automated estimates of bone mineral density (BMD) based on routine X-rays.
In addition to BMD estimates, OsteoSight also generates an osteoporosis classification, based on World Health Organization (WHO) guidelines, which can be included in radiology reports, according to Naitive Technologies, the developer of OsteoSight.1
The Bone Health and Osteoporosis Foundation has projected an estimated $25.3 billion in annual direct health-care costs for three million osteoporosis-related fractures in 2025.2
OsteoSight emphasized that automation of BMD estimates with routine X-rays may lead to earlier diagnosis of osteoporosis cases and allow the use of preventive measures to help protect patients from fragility fractures.
"While treatments exist that can help slow the progression of bone loss, the biggest challenge we face is the persistent underdiagnosis of osteoporosis and low bone density," said Robert Pignolo, M.D., Ph.D., a professor of Medicine, Geriatric Medicine and Gerontology at the Mayo Clinic and member of the Scientific Advisory Board of Naitive Technologies.
"Patients are still being diagnosed after a fracture, instead of during a period of timely intervention. By screening patients who are having routine X-rays, we have a real opportunity to identify early bone loss and osteoporosis and prevent fractures. I'm delighted that the FDA has seen OsteoSight's potential, and I'm excited to see the difference it will make in clinical practice."
Recent Videos
Related Content
New Collaboration Offers Promise of Automating Prior Authorizations in Radiology with AI
March 26th 2025Article
In addition to a variety of tools to promote radiology workflow efficiencies, the integration of the Gravity AI tools into the PowerServer RIS platform may reduce time-consuming prior authorizations to minutes for completion.
Strategies to Reduce Disparities in Interventional Radiology Care
March 19th 2025Article
In order to help address the geographic, racial, and socioeconomic barriers that limit patient access to interventional radiology (IR) care, these authors recommend a variety of measures ranging from increased patient and physician awareness of IR to mobile IR clinics and improved understanding of social determinants of health.
