For the first time, Samsung has received FDA 510(k) clearance for its S Health app. The categorization of the clearance as a cardiology signal transmitter suggests that the clearance will allow S Health to interface with additional connected medical devices in the United States.
Samsung's S Health app originally launched for Galaxy S III users in the UK in the summer of 2012. At the time, it received data from Lifescan’s OneTouch UltraMini/UltraEasy Blood Glucose Meter via a USB connection. It also worked with Omron’s blood pressure monitors and one of its body composition scales via Bluetooth, and similar devices from A&D.
That release never found its way to the US, possibly because of FDA clearance concerns. S Health finally launched in the US with the Galaxy S4, but rather than connecting to third party medical devices, it relied on manual entry and purported to connect to three devices from Samsung: a weight scale, a heart rate strap, and a wrist-worn activity tracker. Those devices have still not been made available for purchase in the US, although the weight scale and heart rate strap can be purchased in Samsung's UK store.
“S Health peripherals, specifically the Heart Rate Monitor Band and Connected Weight Scale, will be available before the end of the year,” the company told MobiHealthNews in an email last August. “Samsung is working on perfecting the S Band and will announce when we’re ready for its commercial launch.”
Meanwhile, Samsung has continued to work on the S Health app is several ways. In August the company added gamified avatar characters to the Korean version of the app. In October, Cigna and Samsung announced a multi-year partnership to enhance the app with content from Cigna.
Samsung filed for clearance in July 2013. If FDA clearance is the factor that has held the company back from launching the various UK device connectivity features in the United States, this clearance could pave the way for rapid changes for US Samsung customers.