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junko.yoshida
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Blogger
FDA approval
junko.yoshida   3/27/2014 10:50:48 AM
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Actually, when I first read articles that detailed Apple's meetings with FDA, I remember I was really happy about it.

Why?

It's because I know almost all the m-Health device vendors are avoiding to seek FDA approval (because it takes too long) and opt for labeling their product "home health care device" rather than "medical device."

As I said, I totally understand why they need to do that. But if any m-Health devices eventually need to talk to a doctor's office (by sending the collected data) and the doctor accepting it (without doubting its accuracy), m-Health device needs to be approved by FDA.

Otherwise, where does the data you collect on your little portable device is going to go? Will that be ever useful to anyone? Well, it's good for your own satisfaction, but seriously, will it ever become useful? 

rick merritt
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Author
Where's the IBand?
rick merritt   3/27/2014 10:54:38 AM
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I'm not sure health and fitness tracking is a very big and broad market...I don't care how many steps I take, what my heart rate is or calories consumed...but if anyone could create a cool consumer wearable service it would seem to be Apple...so where are they?

Caleb Kraft
User Rank
Blogger
Re: Where's the IBand?
Caleb Kraft   3/27/2014 11:03:35 AM
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I think it is still going to take a little time for them to figure out what wearables are going to be utilized. Fitness is an easy market. These are people who are already measuring easily measurable things (like heartrate, calories, steps, etc). Fitness people are also passionate about what they are doing and have created a decent market (look at nike!).

Give them some time, they'll expand beyond simple bio metrics.

junko.yoshida
User Rank
Blogger
Re: Where's the IBand?
junko.yoshida   3/27/2014 12:49:06 PM
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@Rick, you may say that you don't care how many steps you take. That's because you are an avid jogger. The rest of the world seems to care.

When I was recently in China, one guy who is designing smart watches said, "Well, if you can throw in any fitness related stuff in here, it would sell well in China." Hope it's true.

But I had NO idea how big this fitness craze in China is!

AZskibum
User Rank
CEO
Re: FDA approval
AZskibum   3/28/2014 10:15:13 PM
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Good point, and even if this data is only used by the consumer, when home health devices start measuring things like blood pressure & glucose levels, they begin to cross that line where there must be treated as medical devices. A diabetic may make decisions that have medical consequences based on such a reading. It's unrealistic to believe that such data would not influence the user's behavior just because the device is called a "home health device" rather than an FDA-approved medical device.

junko.yoshida
User Rank
Blogger
Re: FDA approval
junko.yoshida   3/29/2014 12:46:33 AM
NO RATINGS
Exactly. I am glad that I am the only one smelling some troubels down the line...



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