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| The Galaxy S5 smartphone--Courtesy of Samsung |
Samsung dodged a bullet in South Korea now that regulators there have decided not to regulate the company's Galaxy S5 smartphone--made with a built-in heart rate monitor--as a medical device.
Korea's Yonhap News Agency reported that regulators would not classify the phone as a healthcare instrument/medical device, though current law could have done so because no legal distinction exists between heart rate monitors used for medical tasks, such as diagnostics, or non-medical purposes, like exercise. Samsung's sensor with the Galaxy S5 is designed to be connected to smartwatches to monitor the wearer's heart rate during exercise, and the highly-anticipated phone risked the more demanding, and expensive, regulatory distinction as a result.
South Korean law mandates that any equipment used to diagnose, treat or prevent diseases requires marketing approval from the country's Ministry of Food and Drug Safety. So the ruling is essentially an exception for Samsung, according to the story. Regulators plan to tweak the regulations moving forward so they have a formal distinction between heart rate sensors used for leisure, like exercise, and those with a defined medical use, the article explained.
Plans call for launching the S5 on April 11 in 150 countries, in tandem with Samsung's Gear Fit--a wrist-watch-sized wearable device. Gear Fit can link to the S5 wirelessly and monitor heart rate.
Apple ($AAPL) is also developing its own technology for a heart monitor inside a mobile device, and the company recently won a patent that would cover how electrocardiogram sensors are installed at multiple points along a phone's casing. Such a phone might require FDA regulatory approval. Perhaps not coincidentally, Apple executives met with FDA device regulators late last year.
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