Withings iPhone Blood Pressure Consumer Device Gets Clearance From FDA

Here’s a little recap below from the CES show where Withings announced the product along with a video at the link.

Here’s a little recap below from the CES show where Withings announced the product along with a video at the link.

Withings Blood Pressure Monitor Sends Your Information to an iPhone And to Google Health and HealthVault PHRs (Video)

“At CES in Las Vegas this week there were all kinds of new devices shown and some will make it and some won’t but this one looks like a winner. You may have already read about the Withings blue tooth and WiFi Scale at the Quack and now they are adding on the Iphone/Ipad connection for taking your blood pressure.

Just like the scale, you can also have our blood pressure readings sent to your PHR, Google Health and HealthVault. This is getting pretty good with the basics going right into a PHR with blood pressure and weight.”

Withings WiFi Connected Body Scale Integrates with Microsoft HealthVault To Use WiFi to Record Your Weight

I don’t know about the blood pressure product but the scale uses 2D bar codes along with Google Health and Healthvault to insure privacy and I wrote about this a while back in March of last year.

Connecting HealthVault/Google Health and More to RazCode Encrypted Microsoft Tags – Automate Data Input

In April of this year the FDA new rule came into play for MMDS medical devices with rules for Class 1 items. I said at that time if unsure, register and this applies to devices that transmit data and you can see blood pressure devices are right in here. The Class 1 rule is for devices that don’t affect a patient’s care, like an automated IV machine as an example that dispenses medications and reports data as that’s a higher classification.

FDA Rule Regarding Medical Device Data Systems Takes Effect–MMDS (Medical Device Data Systems) Rule For Class 1 Devices

In addition there are other options available with using encrypted gateways to secure transmission of data with bar codes. Last week with all the hacking taking place, the post below with using “soft tokens” stored in a cell phone was very popular. Here’s the video below showing how it works with HealthVault and again Withings is set up with 2D bar codes too for the scale.

“Auth Tag” – Mobile Microsoft Bar Code Tags Using a Smartphone To Scan for Two Factor Authentication Giving Users Digital Tokens

HealthVault Razcode–Health Jibes

I’m not sure if or when the blood pressure device from Withings will be connected but it could very well be on the way for secured connections. Using 2D bar codes are almost easier than making a phone call with your phone today. There are a couple more videos at the link above, and one directly speaks about Auth Tag and how a soft token could be the answer to carrying around a key fob for enterprise access to networks too. I would think that all types of agencies would be interested in this possibility and certainly one more item for the FDA to look at when clearing and registering MMDS (Medical Device Data Systems) with the new ruling in place. Here’s the video on how the Withings Scale works below and the goal of HealthJibe is to connect more devices as they are approved to provide secure transmission of personal information.

At any rate, back on topic here Withings now has the FDA stamp of approval for the device that will work with Smartphones and the Ipad. The HealthJibe account is the encrypted gateway used to securely connect devices and the software. BD

Withings announced that the FDA has provided its iOS-powered blood pressure monitor with 510(k) clearance, and the company wasted little time making the device commercially available in the US. The FDA filed 510(k) clearance for the device about one month ago — on May 20, 2011 and the device went on sale over the weekend.

FDA clears Withings iPhone blood pressure cuff | mobihealthnews