CDRH Is Testing New Decision Methods That Could “Change Everything”

FDA's device center is pursuing a pilot study of "quantitative" methods for evaluating data that some say could be the beginning of a complete overhaul in the way regulatory decisions are made

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Germany Readies For Its EPR October Revolution

 
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Germany’s electronic patient record – ePA – is a flagship initiative of the ongoing national healthcare reform. The medtech industry welcomes rollout of the ePA while calling for further improvements.

Execs On The Move: August 18–22, 2025

 
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An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

No EUDAMED, No Market: ‘Waiting Until Mandatory Deadline Is Risky’

 

EirMed CEO Richard Houlihan warns that EUDAMED (the European database on medical devices) publication delays may harm medical device manufacturers. Currently, only a fraction of the required uploads have occurred, creating potential compliance risks as the mandatory deadline approaches.