Samsung’s Galaxy S5 won’t be considered a medical device in South Korea
Samsung’s shiny new Galaxy S5 packs quite a stats monitoring punch with the help of S Health. While the FDA has approved the software companion for the US, it seems the same label won’t be applied in South Korea. The app does meet the criteria laid out by the regulations, but the governing body cited the confusion that could surface from classifying a consumer device like a smartphone as a medical gadget as the main reason for the denial. In order to clarify the formal requirements, regulators will rework to the law to be more precise in its parameters. 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, blood pressure and body composition 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.
Filed under: Cellphones, Software, Mobile, Samsung
Via: Talk Android
Source: Yonhap News (Korean)
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