FDA Flips the Switch on Pelvic Mesh Manufacturers

FDA has ordered Boston Scientific and Coloplast to stop selling surgical mesh intended for transvaginal repair of pelvic organ prolapse. Patient advocates say the action was not made soon enough and does not go far enough, but it is a step in the right direction.

Dirty Scopes Are Still a Big Problem

FDA-mandated studies indicate higher than expected levels of contamination on duodenoscopes after reprocessing.

Taking a Deeper Look at Device Certification and Recertification

Experts discuss how to prioritize medical and IVD devices under the new MDR/IVDR in Europe.

Key Medical Packaging Standard, ISO 11607-1/2 Published; More Regulatory Support on the Way

With the EU Medical Device Regulations just over one year away, this latest revision aims to help medical device manufacturers meet the regulation’s General Safety and Performance Requirements.

SO 80369: Frequently Asked Questions, Answered

Here are answers to some common questions about developing and testing small-bore connectors.

8 Things You Should Know about the EU MDRs

Respondents to a recent survey on the new EU regulation raise some concerns about readiness. Are you prepared?

8 Things You Should Know about the EU MDRs

Respondents to a recent survey on the new EU regulation raise some concerns about readiness. Are you prepared?

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Considering Old and New 510(k) Predicates

span style=”font-weight:normal;”>Is a new device necessarily better?

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Another Reason to Update Your Biocompatibility Approach: EU MDRs

A chemist and biocompatibility expert offers the latest insights and predictions on medtech biocompatibility testing.

How Is the Government Shutdown Impacting Medtech?

FDA cannot accept new 2019 user fees during the government shutdown, which means the agency cannot accept new medical product applications.