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Is Samsung’s Galaxy S5 a medical device?


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In what could be a harbinger of questions in other jurisdictions, South Korea is mulling over whether the Galaxy S5 from Samsung is a medical device. At issue is the built-in heart monitor on the device.

In the US the device is probably ok since it is designed as a fitness device and these have got a pass through FDA’s “enforcement discretion.”

Source: Fierce Medical Devices

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