The U.S. Food and Drug Administration (FDA) published an updated final guidance on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and ...
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. The document, which the FDA released Thursday, is the ...
The biocompatibility, or reaction of some zirconia ceramics, in particular 3mol% yttria stabilised tetragonal zirconia polycrystal (3Y-TZP) to physiological environments or simulated physiological ...
However, that costs time and money, and the document looks the same as the one on the FDA Web site. Due to the lack of easily obtainable information, an engineer or regulatory affairs officer may ...
Medical implants have transformed healthcare, offering innovative solutions with advanced materials and technologies. However, many biomedical devices face challenges like insufficient cell adhesion, ...
Blocking TCA Cycle Enhances T Cell Antitumor Response by Inhibiting the Thrombospondin 2 Signaling Pathway Associated With Endoplasmic Reticulum Stress Gel biocompatibility was tested with two ...
Learn which nanocarriers matter now (LNPs, exosomes, polymers) and the key hurdles in biodistribution, safety, CMC, and ...
A corneal reshaping inlay made of biosynthetic collagen to correct presbyopia is under study in Europe. “Corneal inlays for presbyopia have been around for some years. I tried them all but was ...
Image of an in vitro irritation test courtesy Nelson Laboratories. Biocompatibility testing requirements for medical devices are changing. "A lot of things are happening, on all fronts," Thor Rollins, ...
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