AI for opportunistic osteoporosis screening inks FDA clearance
The U.S. Food and Drug Administration this week cleared an artificial intelligence tool designed to help practices identify patients’ osteoporosis risk using standard X-rays.
OsteoSight, which was developed by London-based Naitive Technologies—a company that specializes in AI-driven software—analyzes routine hip and pelvis X-rays for signs of low bone mineral density. It was designed with the help of frontline providers who sought to create a tool that can integrate easily into orthopedic practices. If the tool identifies anything that would indicate higher risk, it generates a report for the ordering provider. This could enable earlier intervention without disrupting routine workflows.
“This technology enables the orthopedic community to identify patients with poor bone health, who otherwise go unnoticed,” Javad Parvizi, MD, former president of the American Association of Hip and Knee Surgeons, said in a release. “Having this insight at the point of care can help surgeons intervene earlier, improve surgical planning, and enhance patient outcomes.”
Opportunistic screening of osteoporosis is something many providers have expressed interest in when it comes to AI applications. While dual-energy X-ray absorptiometry (DXA) exams effectively identify signs of the condition, these scans are widely underutilized. It is estimated that less than 25% of eligible patients in the U.S. complete the recommended osteoporosis screening, leaving them vulnerable to the risks of major fractures. By turning routine imaging patients are already undergoing into an opportunity for proactive bone health assessment, AI software has the potential to offer both practices and patients significant benefits.
The AI system was rewarded Breakthrough Device designation by the FDA in 2023 and has been tested in multiple clinical studies. Now that Naitive have earned FDA clearance for their software, the company plans to launch commercial partnerships in the U.S.
Learn more about the technology here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.