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 ...

Zirconia is widely regarded as a promising alternative to titanium for bone and dental implants because of its aesthetic ...

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 ...

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 ...

The Department of Science and Technology (DOST), through the Biomedical Engineering for Health (BIOMED) Program of the DOST Philippine Council for Health Research and Development (PCHRD), showcased ...

Biocompatibility testing is a necessary part of any medical device validation process. It is governed by FDA’s ISO 10993 guidance document, a seemingly rigid statement that provides a general matrix ...

Gel-based flexible sensors provide a breakthrough in health monitoring, combining stretchability and biocompatibility for ...

Medical implants and biomedical devices often cause inflammatory responses due to poor biocompatibility. Apatite coatings offer a potential solution but limited cell adhesion is often a challenge. To ...