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Analysis

AI in med tech: how should it be regulated?

In May, the FDA approved an innovative AI-driven algorithm to support clinical decision-making at the point of care. But, regulatory standards are only in the early stages, with FDA head Scott Gottlieb writing recently about setting transparent standards to accelerate the entry of AI advances into the med tech space. What are the dangers of holding back on strong AI regulation in healthcare, and what benefits could effective regulation provide?

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Driving towards the implementation of the new Medical Devices Regulations (MDR)

  On 5 April 2017, two new Medical Devices Regulations (MDR) on medical devices were adopted, and they entered into…
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