Naitive® Technologies, a leading population health company, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its innovative technology, OsteoSight™. This technology focuses on estimating bone mineral density (BMD) using routine X-rays and aims to address the current issue of underdiagnosed osteoporosis, a condition marked by a gradual decrease in bone density often unnoticed until a patient experiences a fragility fracture.
OsteoSight is designed to improve detection rates by analyzing the vast number of daily X-rays, providing an automatic estimate of bone density and an osteoporosis classification based on World Health Organization (WHO) guidelines in the radiology report. This proactive approach allows physicians to be alerted earlier to their patients' bone health, facilitating timely intervention before the occurrence of fragility fractures.
The FDA's Breakthrough Device Program expedites the development, assessment, and review of innovative devices like OsteoSight, with the goal of offering patients quicker access to medical technologies that have the potential to enhance the treatment or diagnosis of life-threatening or irreversibly debilitating diseases. This regulatory recognition underscores the significance of OsteoSight in addressing the persistent challenges associated with underdiagnosis of osteoporosis and low bone density.
By integrating bone density estimation into routine X-rays, OsteoSight represents a promising advancement in healthcare, aligning with the broader trend of utilizing technology for early detection and intervention to improve overall patient outcomes.
https://www.prnewswire.com/news-releases/naitive-technologies-osteoporosis-screening-tool-secures-breakthrough-designation-301950963.html
