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Samsung's Galaxy S5 won't be considered a medical device in South Korea

Billy Steele
March 17, 2014
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Samsung's shiny new Galaxy S5 packs quite a stats punch with built-in sensors and the help of S Health, but the monitoring of vital signs could lead to regulatory issues. Officials with South Korea's Ministry of Food and Drug Safety had been reviewing the handset, and today it ruled that Samsung would not be forced to get formal approval as a medical device. The GS5's heart-rate sensor subjects it to stricter regulations under current laws due to the fact that it monitors organ function. In order to clarify the requirements, Korean regulators will rework the parameters in regards to how it classifies everyday gadgets for fitness use. This could lead to a similar process to that of the US, where consumer pulse sensors are not subject to approval from the Food and Drug Administration. S Health was approved as a "cardiology signal transmitter" by the FDA in the States back in January and originally debuted alongside the Galaxy S III in 2012. Back then, it monitored glucose levels and blood pressure with body composition tallied via a Bluetooth-equipped scale. However, those functions weren't a part of S Health when it finally debuted stateside on the GS4 -- despite another lot of health-minded accessories that were available abroad.

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