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
