Samsung gets FDA clearance for S Health app | mobihealthnews

Samsung gets FDA clearance for S Health app | mobihealthnews:

"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."

'via Blog this'

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mHealth to see big growth, barriers | Healthcare IT News

mHealth to see big growth, barriers | Healthcare IT News:

"A new mobile health trends report released Wednesday underscores the mid- to low sophistication of current mHealth application technology but also emphasizes the explosive growth and integration headed for the market .

The Research and Markets mHealth trends report shows the industry poised for a compound annual growth rate of 61 percent by 2017, to reach a value of $26 billion. This revenue, researchers project, will be derived predominantly from mHealth hardware sales and services."

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Should Mobile Medical Apps Require FDA Approval?

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Updated June 10, 2021

The links in the original post broke.

You can read more about this topic here:

Device Software Functions Including Mobile Medical Applications - FDA.gov

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Should Mobile Medical Apps Require FDA Approval? - Healthcare - Mobile and Wireless - Informationweek:  

Mobile Medical Apps Meet The FDA, Part 2 - Healthcare - Mobile and Wireless - Informationweek: 

A nice pair of articles, fairly and delicately balancing how much is enough, versus too much FDA regulation.

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Is FDA Watching Over Cell Phones as Medical Devices?

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Updated March 24, 2021

People also search for the:

Digital Health Center of Excellence - FDA.gov

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Lately at work I've been noticing some buzz about mHealth, mobile health. The intersection of mHealth, cell phones, and FDA regulation of medical devices seems to be happening, reports this Bob on Medical Device Software post, When Cell Phones Become Medical Devices. According to the post:

Mobile devices are quickly becoming the conduit of choice for collecting and disseminating clinical data. The FDA will soon be forced to step in and take regulatory control. It’s going to happen eventually.

In a nutshell, it's time to start watching this, and paying attention to the possibility of having to follow FDA medical device regulations.  

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