Is your Wearable 510k Approved?

With an estimated 165,000 health related apps for IOS and Android the digital health revolution is far from hype

In an earlier article I wrote about devices at CES 2018 that some wearables were blurring the line into health care device territory. The majority of these products have no FDA approval and the companies that make them are not bound by HIPPA.  As this New York Times article points out, that is changing rapidly. This doesn’t apply to all wearables, I doubt the FDA has time to regulate shoes for your grandma that sends you an alert you if she falls.  Until recently, heart rate, blood pressure, glucose monitors etc. have been in the health care domain.

510k Streamlined Process

KardiaBAnd 510kFor its part the FDA has shown they are willing to shorten the process to change that. A set of industry standards and procedures intended to streamline FDA approval for wearables. However, the race for 510k approval got a head start before the new program was ever announced. By the end of 2016 there were already 36 companies that received 510k approval for mHealth related devices. The majority of approvals were for companies that had an established healthcare device track record. Approvals included manufacturers like Omron, Abbott and Medtronic, vs Garmin and Fitbit.

In November of last year AliveCor received FDA approval for KardiaMobile, a watch band that that includes an electrocardiogram. KardiaMobile’s function is to detect AFib/AF Atrial fibrillation, a common arrhythmia that can lead to stroke.

The Kardia band is the first Apple Watch accessory to receive approval from the Food and Drug Administration.
“It’s changing the nature of the relationship between patient and doctor,” he said, adding that doctors will no longer be “high priests.”
Vic Gundotra, chief executive of AliveCor 

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