Naitive® Launches OsteoSight™ Following FDA 510(k) Clearance for Bone Health Assessment

Naitive® Launches OsteoSight™ Following FDA 510(k) Clearance

Naitive Technologies is making strides in orthopedic care with the recent announcement that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking product, OsteoSight™. This AI-enabled solution uniquely allows for the opportunistic assessment of bone mineral density (BMD) via standard X-rays that are typically conducted for other clinical assessments, such as diagnosing arthritis pain or evaluating fall-related injuries.

Significance of OsteoSight™

Osteoporosis, which leads to a gradual diminishment in bone mineral density, is a condition that impacts millions of people across America and burdens healthcare systems with substantial costs each year. Shockingly, research indicates that about 70% of individuals suffering from low BMD remain undiagnosed until they experience a fracture. The timely identification of these patients can facilitate earlier interventions, thus mitigating the severity of osteoporosis symptoms and enhancing overall health outcomes.

With the support of OsteoSight™, orthopedic practices are equipped to participate more effectively in osteoporosis management. By facilitating early diagnosis, the technology promises to create new avenues for preventive care and growth opportunities within healthcare practices.

OsteoSight™ had already earned recognition as an FDA Breakthrough Device in 2023. This accolade underscores its potential impact in transforming how orthopedic issues are assessed and managed, a sentiment supported by findings from rigorous peer-reviewed research.

How OsteoSight™ Works

The innovative OsteoSight™ technology analyzes routine X-rays of patients aged 50 and older, focusing particularly on the hip and pelvis regions. It effectively identifies individuals at risk for low BMD and generates reports that provide insights to the interpreting physician. This immediate data allows for prompt clinical evaluations of bone health, potentially leading to quicker and more informed decision-making concerning patient treatment plans.

Dr. Javad Parvizi, a prominent voice in orthopedic surgery and former President of the American Association of Hip and Knee Surgeons, emphasized the importance of this advancement, stating, “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.”

Vision for the Future

Expressing pride in this milestone, Dr. Will Briggs, CEO of Naitive, noted, “This 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 the FDA clearance obtained, Naitive is now poised to establish commercial partnerships aimed at introducing OsteoSight™ into orthopedic practices throughout the United States.

This innovative technology marks the commencement of Naitive's journey to develop a comprehensive bone health platform. The aim is to extend proactive patient care, improve overall outcomes, and establish new growth opportunities for healthcare providers.

Naitive Technologies, powered by academic insights from esteemed institutions such as Oxford and Cambridge, is committed to redefining orthopedic care by building intelligent solutions geared towards early identification and treatment of patients at risk. Through this commitment, the company envisions creating an ecosystem that not only enhances health systems but also brings better outcomes for patients grappling with musculoskeletal health issues.

To learn more about Naitive Technologies and its revolutionary OsteoSight™ product, visit naitive.com.