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 ...
Scientists from the Tokyo Medical and Dental University (TMDU) used photoelectrochemical measurement and X-ray photoelectron spectroscopy to clarify the source of titanium's biocompatibility when ...
Treatment of various ophthalmic diseases such as viral infections, macular degeneration, and diabetic retinopathy is difficult, in part due to challenges associated with drug delivery to ocular ...
Intramuscular implantation assesses local tissue response to an implanted material for the ISO 10996-6 implantation test. However, manufacturers are on their own when it comes to how best to fulfill ...
University of California, Los Angeles and University of California, San Diego researchers developed an injectable sealant for rapid hemostasis and tissue adhesion in soft, elastic organs. Formulated ...
The US Food and Drug Administration (FDA) has updated its guidance on biocompatibility issues medical device sponsors should consider in their premarket submissions. This is the second time the agency ...
A practical session on biological evaluation of medical devices: ISO 10993, US FDA & EU MDR expectations, and chemical characterization. Hosted by TUV SUD with Medtronic. Join the RAPS Twin Cities ...
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