Naitive receives FDA 510(k) clearance for AI-enabled opportunistic bone health assessment
Naitive Technologies, a medical technology company developing AI-driven software to reimagine orthopedic care, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its flagship product, OsteoSight.
OsteoSight enables opportunistic assessment of bone mineral density (BMD) using standard X-rays acquired to investigate other clinical concerns, such as pain associated with arthritis or a fall.
Dr Javad Parviz is former President of the American Association of Hip and Knee Surgeons (AAHKS).
Parviz said: “The FDA’s clearance of OsteoSight technology represents a critical step forward in orthopedics.
“By utilising 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.
“Having this insight at the point of care can help surgeons and practices intervene earlier, improve surgical planning, and ultimately enhance patient outcomes.
“This technology is truly unique and innovative.”
Osteoporosis, characterised by the progressive loss of BMD, impacts millions of people and costs healthcare systems billions each year.
Yet, 70 per cent of patients with low BMD are undiagnosed often until a fracture occurs.
Earlier diagnosis drives earlier intervention, improving outcomes and reducing the condition’s impact.
OsteoSight is designed to enable orthopedic practices to take a proactive role in osteoporosis management, supporting earlier interventions, and new growth opportunities for practices.
The device earned designation as an FDA Breakthrough Device in 2023 and has been validated in peer-reviewed research.
Developed with a range of world-leading partners and front-line clinicians, OsteoSight addresses an urgent unmet clinical need, with a solution that fits seamlessly into the existing orthopedic workflow.
OsteoSight analyses routine X-rays of the hip or pelvis in patients 50 years and older and opportunistically identifies cases at risk for low BMD.
It then provides a notification in the form of a report to aid the interpreting physician and prompt a clinical assessment of bone health.
Dr Will Briggs, CEO of Naitive, said: “We are proud that OsteoSight has received FDA 510(k) clearance.
“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.”
With FDA clearance, Naitive is advancing commercial partnerships to bring OsteoSight into orthopedic practices across the US.
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.
