
Japan recognizes Cyberdyne’s robotic suit as medical device - adventured
http://www.japantimes.co.jp/news/2015/11/26/business/tech/homegrown-robotic-suit-gets-recognized-medical-device-japan/
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patio11
If you thought your startup was taking a while to get going, I watched a demo
of this product (to riotous applause) happen in _2005_. I think they started
taking commercial orders sometime before '06.

Here's their financial results from two weeks ago, which if you read not-even-
that-closely will suggest a few of the ways the Japanese startup ecosystem is
borked.

[http://www.cyberdyne.jp/company/download/20151113_financialr...](http://www.cyberdyne.jp/company/download/20151113_financialresultssummary1.pdf)

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rgbrenner
2005 would be about 7 years after the first prototype. He says he started
working on it in 1989:

[https://en.wikipedia.org/wiki/HAL_(robot)](https://en.wikipedia.org/wiki/HAL_\(robot\))

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saulrh
Didn't know this was a medical device. Was expecting it to be classified more
like a ladder or a pair of shoes. On the one hand, being a medical device
means that it can be purchased with insurance money and by hospitals and so
on. On the other hand, having done some work with robotics and having glimpsed
the regulations involved in being a "medical device"... If the European and
Japanese regulations are anything like the American ones, may Turing have
mercy on their developers' shells.

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icegreentea
Well, they have non-medical versions of their products.

What getting the medical device rating means depends on the medical device
category. I have no idea how Japan works, but for FDA (and they have submitted
for FDA approval, they're currently waiting) they've submitted it as a de novo
device, which should go ahead and create a brand new product category once
(if?) its approved.

They do not need clinical trials for their product, but they'll need a bunch
of testing to basically assure that they've minimized risk to wearer to an
appropriate level, and what that will allow them to do is have doctors
prescribe the use of the device (much like how they might tell you use a
wheelchair or crutches), and then use, make insurance money available for use.

Had they not had medical device clearance, it'd definitely be kinda sketchy
(or at least in the grey zone) to have the doctor suggest it for use.

Oh, and ya, the regs are going to such. They've submitted in November 2014 and
still don't have approval and are expecting to be March 2016. This is rather
long, but not really unexpected given their novelty.

I really hope that they knew what they were getting into and wrote all their
code with the regs in mind. My experience has been that code written from
scratch with knowledge of the regs and process is much better than trying to
retrofit old code into the framework. It's not easy by any stretch and its
still a burden... but its so much less rage inducing.

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nkozyra
I haven't followed this company much but surely the naming was an intentional
P.R. effort and not just a coincidence as is claimed, right?

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Bud
As long as they don't create Skynet, and the Series 800 Terminator, I guess
this is ok.

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Kiro
Not sure why you are getting downvoted. I immediately thought this was related
to the Terminator universe but it seems to be a coincidence?

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tudorw
So this is huge right, medical insurance could now cover some or all of this
devices cost for deployment to a huge number of people.

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Illniyar
Cyberdyne , HAL -Who is in charge of naming in that company, they need to be
replaced promptly.

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TeMPOraL
Why? Naming your company like that is a good joke, IMO. That is, as long as it
lives up to the standards - builds robots, and not photo sharing chat apps.

Personally, I'm still waiting for Alphabet to rename itself to Aperture
Science.

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ehnto
Aperture Google,

We collect your data, because, we can.

For the good of all of us, except the ones we exploit.

Now there's no point crying over every Google Plus,

We just keep on trying until you kick up a fuss.

And the collection gets done, and we have a neat run,

For the people who are, still alive.

(not actual views, it just fit with the song)

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cantread1
I read that as "medival" device and was confused until I read the article.

