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An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials Authors: Owen Faris, Ph.D., and Jeffrey Shuren, M.D., J.D. Author Info & Affiliations Published April 6, 2017 ...
Study: Evidence from clinical trials on high-risk medical devices in children: a scoping review. Image Credit: Sai Thaw Kyar/Shutterstock.com Background Medical equipment is essential in the ...
The results of clinical trials can decide which new medical interventions the public may access later. There are many volunteers for clinical trials, but they don’t always reflect the diverse U ...
Before approving a new medical device, regulators evaluate its safety and effectiveness, which includes consideration of the successful achievement of predetermined clinical trial results.
By working with over 150 medical device companies, Castor’s DCT platform is increasing the efficiency of launching medical device clinical trials by ensuring regulatory compliance, optimizing ...
Merit Medical Systems has enrolled the first subject in the multi-centre, prospective trial, WRAP North America registry, ...
Domestic and foreign medical device companies conducting clinical trials in China should consider submitting comments on the New Draft and should monitor updates for the final version.
Clinical trials are a testing phase for drugs, devices, and procedures. These research studies evaluate the effectiveness and safety of a medical intervention in humans.