
Ultrasound imaging now possible with a smartphone - ph0rque
http://esciencenews.com/articles/2009/04/21/ultrasound.imaging.now.possible.with.a.smartphone
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HeyLaughingBoy
What he's done is impressive to be sure, but getting the build cost down isn't
really the problem; it's the lack of substantial competition that will keep
prices up.

Someone has to build and sell these things and in the US and every other
industrialized nation it will be regulated as a Medical Device. Likely, before
it can be used in developing nations also, it will need some form of
regulation and that's where the high cost comes from.

Designing medical devices, getting them FDA approved, and then building them
to meet the standards, and meeting product support requirements (I think we're
required to provide support 5 years after we stop selling a Medical Device) is
expensive and any company doing that is going to want to recoup their costs.
There's a high barrier to entry in Medical Device manufacture and as long as
that barrier exists, businesses will take advantage of it and the products
will be expensive. For example, the company I work for makes a medical
instrument that costs us about $60,000 to build. We sell it for around 10x
that.

His $500 probe will probably end up being sold for about $7-10,000 by the time
it hits the market.

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jasongullickson
Would it necessarily have to be sold as a regulated medical device if it is
not used as such? There are many companies which sell devices which claim to
function as fetal heart monitors (most of which do not work) which are sold
without regulation.

There are also consumer-targeted EEG, EKG and such devices which provide
medical information but do not claim to be clinical-grade.

I don't know what the law here is, but as long as it was not sold with any
diagnostic claims, and did not recommend any invasive use, would it fall under
regulated equipment?

I do agree however that competition (or lack thereof) will be a determining
factor.

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HeyLaughingBoy
_(most of which do not work)_

That's pretty much the key: if you can make it work in a medically useful
fashion then there's a lot more money to be made selling it as an actual
regulated Device.

As long as you don't make medical claims then it won't be regulated as a
Medical Device, but it would still have to follow other Consumer Product
Safety regulations. Those are much easier/cheaper to meet. The only EEG/EKG
type devices I have ever seen were kits and they didn't provide any medically
useful information.

Ultrasound imager classification is covered here:
[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=884.2225)

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randallsquared
_if you can make it work in a medically useful fashion then there's a lot more
money to be made selling it as an actual regulated Device._

I can't see why this would be true. Selling it for $500 now (and $50 in five
years, as these things go) seems like it would mean an incredibly larger
market than selling it for $7-10K, as you suggest.

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jasongullickson
I've considered building something like this for awhile, I'm curious as to the
electronics required in the probe itself.

I'm sure a "medical grade" version would be quite expensive but I can see a
"baby-monitor"-class device as being a huge hit with consumers.

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josefresco
You got that right, I know about a dozen young couples who would buy one in a
second that are expecting. Anyone know if an 'at home' baby monitor device
exists now?

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a-priori
Any other Star Trek nerds here think this sounds like the beginnings of a
Tricorder?

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msie
It will be great if they make it for the iPhone. OS 3.0 now has support for
external peripherals in the SDK.

