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How The EU Needs To Address Conflicts Between AI And Medical Device Rules: Part 1

 
• By Amanda Maxwell

There are serious concerns about how the EU’s proposal for a new Artificial Intelligence Act could disrupt the regulation and supply of medical devices in a few years. Royal Philips’ Koen Cobbaert, explains the challenges in detail in this first part of a two-part interview piece.

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The EU’s proposal for a new Artificial Intelligence (AI) Act is set to have a “massive impact” on medical devices and IVDs.

More work is needed to address the current misalignments between the proposed horizontal Act, which will be superimposed on many...

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A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 
• By Brian Bossetta

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