Lucideon launches new biocompatibility lab to support a new era in patient safety

Lucideon - new biocompatibility lab in the US International technology company Lucideon is forging a new era in the ...
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 ...
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 ...
MD&M East

Cytotoxicity Testing for Medical Devices: A Guide to Compliance & Best Practices

Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...
RAPS

FDA publishes new dataset to aid medical device biocompatibility testing

The US Food and Drug Administration (FDA) has published a chemical dataset that analytical laboratories can use to demonstrate they can detect chemicals that may not be biocompatible for use in ...
Business Wire

IntraSense™ – Medical Device Biocompatibility

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.
MyCentralJersey

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 ...
Medical Design & Outsourcing

The real challenge of medical device extractables and leachables testing

Regulators increasingly want medical device manufacturers to begin with a more precise understanding of their product's ...
Design News

Using Precious Metals for Medical Devices

Tanaka Senior General Manager Kunihiro Shima shares insights on custom alloy composition, processing, tariffs, precious metal ...
The Desert Sun

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

NEW YORK, NY, UNITED STATES, January 26, 2026 / EINPresswire.com / — STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the expansion of ...