Since 2000, the FDA has explicitly described the importance of radiographic evaluation in spinal studies in primary and secondary endpoints.
FDA recommends using imaging of the sinuses as a secondary efficacy endpoint for drugs being developed to treat chronic rhinosinusitis with nasal polyps (CRSwNP).
Semi-automated quantitative measurements of sinus inflammation from 3D CT imaging correlate well with clinical outcomes.
Facing an aging population and unprecedented scrutiny over treatment costs, clinical trials that seek to improve treatment of late-stage conditions and diseases such as osteoarthritis are set to make a significant impact.
A new study finds that small brain lesions previously thought to be insignificant are associated with heightened risk of stroke, increasing the importance of utilizing the very best medical imaging technology and experienced readers.
As technology evolves and medical devices change as a result, creating even more challenges for regulators, clinical trial designs must adapt to the emerging trends.
Drs. T.J. Mosher and G.E. Gold, two of MMI’s thought leaders, recently were published in a review of the best practices for knee OA imaging in clinical trials.
Sponsors of extra-U.S. trials need to carefully monitor the FDA’s requirements for the submission of foreign data.
The administration’s most recent release clears up what is necessary for developers to successfully approach specialized medical device advisory committee (MDAC) panels.
Total shoulder arthroplasty (TSA) is becoming increasingly more common as a treatment for disabling pain or impaired shoulder function. Dr. Jonelle Petscavage, a Medical Metrics’ (MMI) consultant, recently published a two-part review in the American Journal of Roentgenology on the current state-of-the-art in shoulder arthroplasty. Covering topics such as epidemiology, history, preoperative imaging, hemiarthroplasty, anatomic …
