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 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 ...

The biocompatibility, or reaction of some zirconia ceramics, in particular 3mol% yttria stabilised tetragonal zirconia polycrystal (3Y-TZP) to physiological environments or simulated physiological ...

Mg alloys have received considerable attention as biomaterials due to their biocompatibility, biodegradability, and density and elastic modulus comparable to bone. These qualities make them suitable ...

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, ...

(Nanowerk Spotlight) Any drug intended for systemic administration and all medical devices which will contact blood (e.g. oxygenators, tubing, catheters, artificial hearts) must undergo thorough ...

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, ...

Research into the synthesis of new materials could lead to more sustainable and environmentally friendly items such as solar panels and light emitting diodes (LEDs). Scientists from Ames National ...