FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...

MILPITAS, Calif.--(BUSINESS WIRE)--SMI (Silicon Microstructures, Inc.) is pleased to announce that biocompatibility of IntraSense™ has been confirmed at a major medical device manufacturer.

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 ...

Biocompatibility testing is performed on medical devices to ensure that they will not cause any adverse effects once in contact with or implanted into a patient, and as a standard, all such devices ...

BOENNIGHEIM, Germany and LIGONIER, Ind., Nov. 4, 2025 /PRNewswire/ -- Hohenstein Medical – a division of Hohenstein Laboratories and a leading provider of testing, research and certification services ...