Dr. Mark Schweitzer, MD, expounds on design and reporting considerations for imaging assessments in research publications.
Insights from the 2022 OARSI Clinical Trials Symposium
In a research letter in Spine, MMI collaborated with researchers to investigate the SPSI as an objective measure of instability in lumbar stenosis patients with degenerative spondylolisthesis.
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.