The first iPhone medical device: Jazz meter?

By: Brian Dolan | Jul 9, 2010

WaveSense iPhone Jazz Meter Salem, New Hampshire-based Agamatrix already has a popular diabetes management app available for iPhone users: The WaveSense Diabetes Manager app currently has 50,000 users, according to a report over at DiabetesMine. Like many diabetes apps, Agamatrix’s requires users to manually enter glucose data. That could change soon.

Agamatrix believes that its WaveSense Jazz meter could become the first medical device to connect directly to Apple’s iOS platform, which includes iPad, iPhone and iPod touch. Why isn’t the WaveSense Jazz meter already sending data to the iPhone app? Agamatrix says its new USB download cable, which connects the meter to the iPhone, is currently pending FDA 510(k) review.

Agamatrix told DiabetesMine that the cable will go on sale at “Apple standard pricing” of about $25 to $30 as soon as it garners FDA approval.

“We’ve been working with Apple for the last two years to make this happen. We’re very excited,” Agamatrix’s Strategic Marketing Manager Joe Flaherty told DiabetesMine.

Of course, glucose meters are already sending data to at least one smartphone platform: Earlier this year Nokia made available a smartphone app, MyGlucoHealth, in its Ovi Store that enabled Entra Health Systems’ Bluetooth-enabled MyGlucoHealth meter automatically send updates to Nokia smartphone users’ phones.

Johnson & Johnson company LifeScan also demonstrated a concept Bluetooth-enabled or USB-connected meter that worked with iPhone 3.0 in mid-2009. No new product has launched, however.

Meanwhile, Telcare, a recently launched startup that has at least a couple million in financing, is also working to develop a wireless glucose meter that includes wireless radios from Sierra Wireless and Qualcomm and requires no smartphone companion device. It has all the wireless embedded. The device is currently pending FDA approval, according to the company’s website.

For more on the WaveSense Jazz meter, check out this report from DiabetesMine

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http://www.imedicalapps.com/2010/07/agamatrix-glucose-meter-fda-approval-iphone-connection/ Agamatrix glucose meter may get FDA approval for direct iPhone connection | iMedicalApps

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Marko

Why would this company have to work with Apple for two years to transfer data over USB? Oh yes, this is Apple who has a very closed system and won’t allow interesting things to be connected to their devices. If it were not for the ridiculous ways Apple makes a system connect to their devices, this could have been done in a month and many other devices could also connect and provide great value. Apple is actually way behind the times in connectivity and I cannot believe so many people are excited about one device being connected to it. We should be very upset that there are not dozens, if not hundreds, of devices connected to it.
Brian Dolan

@Marko, I hear you.

As Bradley Merrill Thompson has pointed out for us in the past, in these cases the iPhone may very well be considered an accessory to the connecting medical device and therefore would need to be regulated in the same way.

While I agree the system is closed in many ways, I think Apple is also incredibly careful and conservative when it comes to FDA regulatory issues. The FDA is certainly “behind” when it comes to making the regulatory environment here clear — so it’s hard to fault Apple for slowing things down — as frustrating as it is for end users and other peripheral device makers.

We just reported on Brad’s progress in terms of the regulatory issues last night. Read more here: http://mobihealthnews.com/8358/update-mhealth-regulatory-coalitions-first-meeting/

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