Since its inception in 2005, O.N. Diagnostics has emerged as the world leader in providing contract research services to academia, government, and industry for patient-specific finite element analysis of bone strength from CT scans, aka Biomechanical Computed Tomography analysis (BCT). Utilizing our unique experience in analyzing CT scans and our patented analysis capabilities, we offer customized BCT services of bones and bone-implant systems.
- Our flagship product, VirtuOst, is the first-ever FDA-cleared BCT software for clinical diagnostic and monitoring purposes and has been used to analyze tens of thousands of CT scans.
- The company's research has supported FDA applications for both pharmaceutical and orthopedic applications, is widely published in leading peer-reviewed journals, and is regularly presented at top international conferences.
- In January 2024, the FDA approved a de novo device (Osteoboost, a vibration device for the lower back, designed to reduce the loss of bone strength and bone density) on the basis of measurements of bone strength and bone density made by VirtuOst, see the Indications of Use. This development sets a precedence at the FDA that the VirtuOst measurements can be used to define endpoints for regulatory approval of new medical devices.
- Our technical staff — comprising PhD-level scientists, biomechanical engineers, software engineers, and IT experts — has deep expertise in all aspects of BCT research, from study design and scan acquisition to statistical analysis and archival.
- In collaboration with our consulting Chief Science Officer and company founder Prof. Tony M. Keaveny (UC Berkeley), we offer invaluable assistance in interpreting and disseminating study results.