The U.S. Food and Drug Administration (FDA) granted 510(k) clearance to Naitive Technologies’ flagship product, OsteoSight, which enables clinicians to assess bone mineral density (BMD) using standard X-rays originally taken for other clinical reasons, such as evaluating pain from arthritis or a recent fall. 

Osteoporosis, characterized by progressive BMD loss, impacts millions of Americans and costs healthcare systems billions of dollars each year. Yet 70% of patients with low BMD are undiagnosed¹ often until a fracture occurs. Earlier diagnosis drives earlier intervention, improving outcomes, and reducing the condition’s impact.² OsteoSight is designed to help orthopedic practices take a proactive role in osteoporosis management and support earlier interventions, thus generating new growth opportunities.

“We are proud that OsteoSight has received FDA 510(k) clearance,” Naitive Technologies CEO Dr. Will Briggs said. “It reflects the dedication of our team and validates the urgency of the problem we are solving. Millions of patients live with undetected osteoporosis, and orthopedic practices are uniquely positioned to change that. With this milestone, Naitive can now deliver real impact to orthopedic practices and their patients and lay the foundation for a broader platform in proactive bone health.”

OsteoSight earned FDA Breakthrough Device designation in 2023 and has been validated in peer-reviewed research.³ Developed with various partners and front-line clinicians, OsteoSight addresses an urgent unmet clinical need, with a solution that fits seamlessly into the existing orthopedic workflow.

OsteoSight analyzes routine hip or pelvis X-rays in patients 50 years and older and identifies low BMD risk cases. It then provides a notification (in report form) to help the interpreting physician and prompt a clinical bone health assessment.

“The FDA’s clearance of OsteoSight technology represents a critical step forward in orthopedics. By utilizing X-rays that are already part of routine practice, this technology enables the orthopedic community to identify patients with poor bone health, who otherwise go unnoticed,” said Dr. Javad Parvizi, former president of the American Association of Hip and Knee Surgeons (AAHKS). “Having this insight at the point of care can help surgeons and practices intervene earlier, improve surgical planning, and ultimately enhance patient outcomes.” 

Having secured FDA clearance, Naitive now is advancing commercial partnerships to bring OsteoSight into U.S. orthopedic practices. The technology is the first step in building a comprehensive bone health platform designed to expand proactive care, improve patient outcomes, and create new growth opportunities for providers, according to the company.

Naitive Technologies is developing artificial intelligence (AI)-driven software to reimagine orthopedic care. the firm aims to solve urgent challenges in musculoskeletal health by building intelligent, pathway-driven technologies that help orthopedic providers surface at-risk patients, convert them to treatment, and coordinate their care, ensuring that every high-risk patient is identified early, treated appropriately, and supported throughout their journey.

References
¹ https://link.springer.com/article/10.1007/s00198-025-07395-3
² https://jamanetwork.com/journals/jama/fullarticle/2829238
³ https://link.springer.com/article/10.1007/s00198-025-07487-0