BMD, Bone Strength, and Load-to-Strength Ratio. The FDA-cleared VirtuOst software is used to assess the effects of aging, disease, or treatment. VirtuOst is cleared to identify osteoporosis, assess fracture risk, and monitor treatments, and our inter-operator measurement precision both for BMD and bone strength (CVRMS < 1.0%) is unsurpassed. The VirtuOst measurements have also been used as an endpoint for FDA regulatory approval of de novo medical devices. Measurements can be made from CT scans acquired with or without an external calibration phantom.
Additional Analyses of Bone Quality. To gain additional insight into treatment effects, we provide measurements separately for the trabecular and cortical compartments and can assess bone strength contributions due to spatial heterogenity and bone size. Morphology measurements can be made for any part of the bone or for soft tissues.
Bone-Implant Analyses. Using our patented technology, we can create patient-specific bone-implant finite element models for virtual stress testing of implants – for a single research subject's bone or for hundreds of bones from our internal database of CT scans. Examples include virtual stress testing of pedicle screws, interbody spinal fusion cages, tibial external fixators, and internal fracture-fixation plates and rods. Parameter studies can be run to refine implant designs, accounting for much of the real structural complexity and heterogeneity of patients' bones.
Study Design and Coordination. O.N. Diagnostics has analyzed tens of thousands of CT scans, acquired from a wide variety of CT scanners, scanning protocols, and calibration phantoms and including a wide range of patient demographics. Leveraging this diverse experience, we are uniquely qualified to assist research groups (large or small) in planning study designs for CT protocols, managing scan acquisition and quality control, and serving as the CT coordinating center for single- or multi-center studies.