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It is important to understand the impact of absorbed moisture content in polymers, as high or low levels could accelerate aging damage in many materials.
FDA’s Jeff Shuren, MD, and Timothy Stenzel, MD, discussed the flaws of the antibody testing guidance in a recently published editorial in The New England Journal of Medicine.
The OPRA Implant System has been on the market under a humanitarian device exemption since 2015 and is now fully approved by FDA for patients who have trouble with conventional socket prosthetics.