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Switzerland: US FDA’s Medtech Can Bridge Innovation Gap Left By MDR

Medtech industry wants more urgency from Swiss authorities to address worsening product shortfall

 
• By Ashley Yeo

Setting the patient safety bar too high will likely have the opposite effect in the case of the EU MDR. So believes the medtech industry in Switzerland, where work has begun at government level to pave the way for Swiss patients to have access to US FDA-approved medtech.

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Switzerland and the EU have begun to experience cases of medtech products no longer being available on their respective markets. The Medical Device Regulation’s more stringent regulatory criteria, its cost to users and persisting lack of structural integrity have compelled some companies to abandon niche and other medtech solutions on the EU market.

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• By Ashley Yeo

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More from Europe

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• By Natasha Barrow

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• By Natasha Barrow

AI systems used in healthcare are vulnerable to adversarial cyberattacks, which are a growing concern, said Atif Azad, a professor of AI at Birmingham City University. Azad’s research group has developed a method that trains AI to become more resilient to cyber threats through the use of random image adjustments.