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Lab Association Asks Congress To Kill FDA’s Final Rule On LDTs

 
• By Brian Bossetta

In a letter to US lawmakers, the Association for Diagnostics and Laboratory Medicine says the FDA’s final rule regulating lab-developed tests will stifle innovation and that Congress needs to step in and stop it.

Rule Exception
• Source: Shutterstock

If the Food and Drug Administration’s final rule placing laboratory developed tests (LDTs) under its regulatory purview goes through as planned, almost half of the labs that now make the tests will stop producing them, according to one of the leading laboratory organizations.

In a letter to House and Senate committee chairs, Anthony Killeen, president of the Association for Diagnostics and Laboratory...

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• By Amanda Maxwell

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New EU Rules Limit Chinese Participation In Medtech Procurement

 
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From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

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• By Brian Bossetta

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By Marion Webb

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June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 
• By Amanda Maxwell

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.