Radiographic spine fusion assessment is complicated by a lack of standardized criteria, highlighting the need for imaging expertise during clinical trials.
Dr. Mark Schweitzer, MD, expounds on design and reporting considerations for imaging assessments in research publications.
A provocative discussion among spinal clinicians, researchers, biomechanicians, and technology engineers regarding the state of spinal diagnostics.
Featuring MMI’s John Hipp, PhD, along with Zorica Buser, PhD, and Charles Reitman, MD.
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).
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.
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.
The Chinese government plans to implement greater scrutiny on the medical device industry with new hefty fines and regulations.
