MD&M East

Biocompatibility Testing: Tips for Avoiding Pitfalls, Part 2

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 ...
RAPS

FDA releases guidance documents on biocompatibility submissions and nitinol-containing devices

The US Food and Drug Administration (FDA) has issued two new guidance documents related to premarket submissions on device biocompatibility with intact skin, as well as technical considerations for ...
RAPS

FDA updates medical device biocompatibility guidance with exclusion list

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 ...
Seeking Alpha

Spiderwort Biotechnologies Inc. Announces Status of Biocompatibility Testing for CelluJuve®

Cellulose dermal filler achieves critical biocompatibility milestones, paving the way for clinical trials OTTAWA, ON, April 29, 2025 /CNW/ - Spiderwort Biotechnologies Inc., a pioneering biotechnology ...
JD Supra

Update to biocompatibility policy for medical devices in contact with intact skin

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 ...
Nature

Biocompatibility of novel albumin-aldehyde surgical adhesive

Many medical procedures could benefit from the use of tissue sealants which allow for reduced surgery time, limited blood loss, easier tissue handling, and fewer postoperative complications. The ...
Nature

Screening for compounds released from deep brain stimulation probes by contact with a brain simulant

Deep brain stimulation involves several neurological conditions in which implantable leads deliver electrical impulses to specific brain regions. While biocompatibility testing is essential for ...
Tennessean

STEMart Announces Enhanced In Vivo Rat Micronucleus Test Services to Accelerate Medical Device Biocompatibility Testing

STEMart announces the expansion of its genetic toxicology capabilities with the In Vivo Rat Micronucleus Test services. NEW YORK, NY, UNITED STATES, January 26, 2026 ...
The Manila Times

New innovations on safer skin test, newborn care, clinical training get spotlight

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 ...
MD&M East

Biocompatibility Testing: Tips for Avoiding Pitfalls, Part 1

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 ...
manilatimes

Innovations on safer skin test, newborn care, and clinical training get spotlight to improve Filipino healthcare

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 ...