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docdivakar
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CEO
re: Seven can't miss highlights at ISSCC
docdivakar   3/2/2011 5:07:29 PM
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@Luis Sanchez: well, if you want to see which tooth has high stress, that is quite easy, we can quote or stick thin-film pressure sensors! Remember those plastic rulers with this feature where you press your thumb to see how stressed you are? We have come a long way from that in advancements of materials technology. Now a days, you can get transparent electronic films that do the same! Overall, I liked most of the 'can't miss' list but I reminisce those days when life was far less complicated! I wonder if we are unnecessarily complicating humanity's survival in the name of technological advancements! Dr. MP Divakar

Jose.Bohorquez
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Rookie
re: Seven can't miss highlights at ISSCC
Jose.Bohorquez   2/21/2011 1:02:26 PM
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It really all depends on the technology. Medical devices are divided into there classes (1,2,3), with class 1 being very simple things like crutches, class 2 being low to medium risk devices like EKG machines, and class 3 devices being high risk or life sustaining devices (think pacemakers). Most class 2 devices require "premarket notification (510k)" and most class 3 require "premarket approval (PMA)". The caveat is that to do a 510k, you need to be "substantially equivalent" to a "predicate device". Confused yet? Wait.. there's more. If you're a class 2 device and don't have a clear predicate, you are automatically classified as class 3 and have to do a PMA... EXCEPT, you can file for a "de novo" review which is much simpler :) Bottom line is that the regulatory process is a big hurdle, but it's not insurmountable; even for a startup. You need good consultants, a solid plan, and a good quality management system. Check out the FDA website; it's actually quite helpful (although there is a LOT to read).

ManasK.RayChaudhuri
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re: Seven can't miss highlights at ISSCC
ManasK.RayChaudhuri   2/21/2011 1:41:51 AM
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The awareness interests me wholly.

Sheetal.Pandey
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Manager
re: Seven can't miss highlights at ISSCC
Sheetal.Pandey   2/19/2011 7:45:34 PM
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Liked the conference details and awareness.

Sheetal.Pandey
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Manager
re: Seven can't miss highlights at ISSCC
Sheetal.Pandey   2/19/2011 7:44:43 PM
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Good questions! I wonder if FDA offers to answer these question on their website on FAQs. I guess working with any government body is just patience...

lifewingmate
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Rookie
re: Seven can't miss highlights at ISSCC
lifewingmate   2/19/2011 5:45:21 AM
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@Don, Thank you for these highlights and for your best tips on how to make the most of the ISSCC. The round table plenaries sound like an excellent new feature. I was wondering on a social media front if there are hash tags and other ways we can track and follow the conference via Twitter, LinkedIn, or Facebook.

Luis Sanchez
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Rookie
re: Seven can't miss highlights at ISSCC
Luis Sanchez   2/18/2011 9:52:13 PM
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The winner for me is the: A Telemetric Stress-Mapping CMOS Chip with 24 FET-Based Stress Sensors for Smart Orthodontic Brackets. I never imagine before putting some electronics in the mouth for teeth purposes. Sounds like a pretty good idea if the do it right. I can imagine the data going to the mobile phone and perhaps creating a stress-scopic image that will show with a color code which teeth are under more stress or so. If we allow our imagination to go even further in the future the brackets might become self adjusting and the visits to the doctor might become seldom. Sorry doctors. Don't worry... that's the far future. :-)

Kinnar
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CEO
re: Seven can't miss highlights at ISSCC
Kinnar   2/18/2011 6:25:41 PM
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It seems that solid state devices with be ruleing the world in the comming days, as the application of solid state devices in now not being limited to transistors and ics it is expanding its horizion.

Charles.Desassure
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Manager
re: Seven can't miss highlights at ISSCC
Charles.Desassure   2/18/2011 4:29:10 PM
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Sound like an interesting conference. Please share more articles about this conference in the future.

rick merritt
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Author
re: Seven can't miss highlights at ISSCC
rick merritt   2/17/2011 1:11:51 AM
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@caiogubel: There are two major FDA pathways. The simplest is called 510(k) aimed at devices similar to things already on the market. I am told it can take 9-18 months to prepare data for it and another 9-18 months to go through the formal FDA process to get it. Costs are all over the map. The more extensive path called PMA for new kinds of devices is longer and more expensive with costs varying greatly for both paths. Anyone please feel free to chime in if you have more detailed info.

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