Wednesday, October 11, 2023
Naitive® Technologies, a company focused on population health, has been granted the Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its innovative solution, OsteoSight™. This technology is developed to estimate bone mineral density (BMD) from routine X-rays, addressing the need for early osteoporosis diagnosis, a condition characterized by a progressive decrease in bone density that often goes unnoticed until fragility fractures occur, representing a substantial healthcare challenge.
Globally, fragility fractures occur every 3 seconds, resulting in a cost of $400 billion to healthcare systems annually. In the United States, osteoporosis-related fractures affect 50% of women and 25% of men over the age of 50, with an associated cost of $57 billion. These fractures lead to more hospitalizations than stroke, breast cancer, and heart attacks combined. Despite this, up to 75% of individuals with osteoporosis remain undiagnosed and untreated.
OsteoSight is designed to enhance detection by analyzing the numerous daily X-rays taken for various reasons. By automatically providing bone density estimates and osteoporosis classification based on WHO guidelines in radiology reports, physicians can identify at-risk patients earlier. Early detection of osteoporosis enables timely intervention to prevent fragility fractures.
Prof. Robert Pignolo, a member of Naitive Technologies' Scientific Advisory Board, stressed the importance of early detection in preventing fractures and expressed satisfaction with the FDA's recognition of OsteoSight's potential.
The FDA's Breakthrough Device Program expedites the development and review of OsteoSight, offering patients quicker access to medical devices for more effective diagnosis and treatment of life-threatening or debilitating conditions.
Dr. Will Briggs, CEO and Founder of Naitive, expressed enthusiasm about the Breakthrough Device Designation, emphasizing its potential to revolutionize osteoporosis risk assessment and enhance patient outcomes.