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Brain Implants Near Milestone

By   10.16.2013 0

SAN JOSE, Calif. — The product Steve Archer started work on 14 years ago is just about to hit the market — he hopes.

The NeuroPace RNS is the first implant to listen to brain waves and autonomously decide when to apply a therapy to prevent an epileptic seizure. It was developed by a company with a staff of less than 90 people, only about 30 on the core electronic, mechanical, and software engineering teams.

Maintaining a lean staff was a conscious decision of managers who have raised $215 million to date and knew the project would take a long time to pass regulatory approvals. “The joke is we have been two years away from an FDA clearance for about a decade,” said Archer.

The FDA now says the company is very close to getting a green light, though it is not giving any specific dates. Indeed, an FDA representative was calling the company despite the recent government shutdown to work out details.

“There are a lot of really sexy engineering fields out there that let you make a lot of money, but the medical sector is very regulated so what takes a few weeks to design in a hard drive takes years in medical,” Archer said.

On the other hand, “there’s a certain feeling when something you personally designed is walking around inside a great number of people — you feel like it sure better work, but it’s more than that,” Archer said, recalling some of the 256 epilepsy patients so far who have been able to lead more normal lives due to receiving the implant in clinical trials.

The work holds promise of advancing brain science, too. For instance, NeuroPace already has discovered patients can have hundreds to thousands of pre-seizure events every day.

“No one else is recording ambulatory brain wave activities from epileptic patients to the extent we are,” Archer said. “We have the world’s largest library of such recordings and that’s a tremendous resource for all sorts of research — the opportunity is huge,” he said.

Indeed, some say today’s deep brain implants are in a stage of development similar to cardiac devices in the early 1980s. They may spawn families of systems addressing a wide variety of neurological disorders.

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rick merritt   2013-10-16 17:27:08

What do you think of the future of neural devices?

Sanjib.A   2013-10-17 10:48:34

Good to see the beginning of medical-electronics understanding brain-waves and helping patients. The way the device is fit into the skull a bit scary to me, so I believe in future devices will be more compact, thin and light weight. The device might no more depend on Li batteries in future, there could be some energy harvesting techniques used to provide power to the electronics as it consumes low power.  

mixed_signal   2013-10-17 12:13:33

Anyone remember Michael Crichton's Terminal Man?...

http://en.wikipedia.org/wiki/The_Terminal_Man

PeteMacKay   2013-10-17 12:47:46

I recommend the book "World Wide Mind" by Michael Chorost. He has an interesting take on a future where implanted brains will be connected together (much like IoT) and our fundamental concrete understanding of communication will change. He asserts that this new nature of communication will take a form closer to that of empathy; I can relate to that because I personally believe humans once had a more important 'sixth sense' called intuition that we evolved away from as we climbed Maslow's pyramid. In the book, Chorost weaves personal experience with stories of actual research projects, interjecting his fantasy scenario along the way and making for an interesting read.

krisi   2013-10-17 13:15:55

Amazing technology...but I am even more impressed that they managed to get $215M in funding...the market is very small and the dollar amount you can charge for one device is not unlimited...hard to justify ROI on such an investment! Kris

Sheetal.Pandey   2013-10-17 14:25:54

If this happens the "brain implants" it would be like science and technology has reached another milestone. Many diseases that made rich and famous fall prey to in la te 60s and 70s are now curable. Its good for the humanity. So many people due to brain damage cannotvlive their life may be this innovation will let them lead normal lives.

Frank Eory   2013-10-17 15:28:56

The implant is disturbingly large, perhaps needlessly so. The article mentioned them using 0.33 or 0.5 um technology to minimize leakage current. Those are enormous transistors. Is that really the best trade-off of chip size vs. leakage power?

rick merritt   2013-10-17 17:12:17

@Frank: You raise a good question: How much of the device size is determined by the chip size. The corrollary is how often do you have to swap out the device for a new battery now and how often would you if you used a significantly more modern process node.

rick merritt   2013-10-17 17:13:17

@Krisi: Yes, and if Mir Imran's comments are accurate the market size may be even smaller than they anticipated.

krisi   2013-10-17 17:47:39

there is nothing wrong with using 0.5um or 0.35um transistors...many medical devices use them...and how would you get 10uW otherwise???

junko.yoshida   2013-10-17 19:31:48

I almost feel like every story we write these days is about "sensing" and how best a certain chip can run the newest and greatest algorithm, and analyze senses!

Bert22306   2013-10-17 20:47:49

You're right, Junko. Reason being, a lot of the most interesting stories have to do with control systems. Sensing what the system is doing is key to controlling that system. So when you take the "man out of the loop," sorry, I meant "person," you have to use automatic sensing.

junko.yoshida   2013-10-18 01:29:40

Yes, Bert, I agree. I have a feeling that stories we will be writing about in the next 10 years are exactly on that battle; how best we can build a system (sensing and control, as you put it) that can take the man out of the loop...

I said "battle," because it wiill be no cake walk, technically speaking; but more importantly, I think this wiill challege our legal, economic and societal conventions and assumptions.

junko.yoshida   2013-10-18 01:30:39

Yes, Bert, I agree. I have a feeling that stories we will be writing about in the next 10 years are exactly on that battle; how best we can build a system (sensing and control, as you put it) that can take the man out of the loop...

I said "battle," because it wiill be no cake walk, technically speaking; but more importantly, I think this wiill challege our legal, economic and societal conventions and assumptions.

rick merritt   2013-10-18 04:21:16

@Bert and Junko: Agreed. I believe the next big phase of computing beyond mobile is this so-called ubiquitous compouting of an instrumented smart world. But this is not my original tho0ught Mark Weiser of Xerox PARC popularized it in the 1980s.

MS243   2013-10-18 10:22:58

It seems to me as though a more advanced packaging approach is  needed.  Still the technology for the use of reducing and controlling the effects of sizures holds great promise for helping the many Veteran's wounded in Afghanistan by IED's.  (Are the rare earth metals there used for electric cars really worth this human cost, or is there a better means of solving the vehicluar power issues -- such as converting air and water into fuel as is being done on a pilot basis in the UK?)

DrFPGA   2013-10-18 10:47:33

Yep, sure do. Maybe thats why just thinking about this application makes the hair on the back of my neck stand up.

Anyone remember the episode of Homeland where the pacemaker was hacked to cause a heart attack? Just think what a neural implat could do if hacked... Ick...

Now I know it's just me, and this technology will eventually help lots of people (maybe even me), but it will take me a while to get used to the idea...

MS243   2013-10-18 11:50:22

Often medical devices use very limited processors and the design studies to not analize the effects of hacking fully -- For example most of the ARM 7 CPU's so common in WiFi and Bluetooth have No MMU making the code that runs on them very vulnerable to hacking -- and little thought or effort is put into this and other hardware based security features that greatly expand the design scope of the projects, as well as expand the hardware and software effort required to prevent issues like this.  What is really needed is a clean slate approach to the next generation of wireless device hardware chipsets that make security first and foremost -- in my mind the security for a medical device should be made unbreakable to protect the life of the patient, as well as the lives of others -- a neural implant that is hacked could be used to trigger violence in an un-suspecting patient for example -- or could be used to condition the patient so their will power is reduced to criminal or other undesireable behavior.

goafrit   2013-10-18 15:45:33

>> The way the device is fit into the skull a bit scary to me, so I believe in future devices will be more compact, thin and light weight

You are correct. I hope the era of nano-electronics will come when some of these advances can be implemented in a more robust way. Footprint is a key factor in this type of product. Very commendable feat and hope they can nail this with FDA approval to help people around the world

rick merritt   2013-10-18 18:58:25

A hacker will have to be pretty sophisticated to figure out how to trigger specific behviors with eight max leads, a few low volt signals in a specific area of the brain!

MS243   2013-10-18 19:43:38

I would venture a guess it could be done with just two electrodes and they would not even have to be within the skull.

prabhakar_deosthali   2013-10-19 02:17:17

Evrything developed today has the hackers threat looming large on it. So why not make such devices stand alone with a physical key access.

Hackers need some connection, some port thorugh which to gain access to a system. But if you make a system such as this implant a stand aone thing then it could remain secure from the hackers and only accessible to the attending doctor or the patient himself.

MS243   2013-10-19 11:41:34

If I understand Nearfield comunications and inductive loop communications they limit the potential range of the medical link to a safer distance -- now these type links need to be bullet proofed vs in-channel over an assumed good link, type attack --  probably harder and more expensive than meets the eye but this may be the best option.

Charles.Desassure   2013-10-20 13:56:59

This is exciting news after 14 years of hard work.  The first implant to listen to brain waves and autonomously decide when to apply a therapy to prevent an epileptic seizure will indeed improve the life of many people.  I cannot wait to hear more.  Hope there will be a follow-up article with more detail information once it hit the market.

rick merritt   2013-10-20 20:48:01

Yeah, there is always a hack and a countermeasure and a hack of the countermeasure and so on

selinz   2013-10-20 23:35:39

Having recentlhy witnessed a grand mal seizure from someone close, I'm happy to see this. At the same time, I think the extended approval period isworthwhile. From what I understand, the current state of anti-seizure drugs are very effective. I'd be curious to know under what circumstances the implants are more or less effective than the state of the art drugs... both are invasive but in different ways.

rick merritt   2013-10-21 12:28:46

@Selinz: Wow, I haven't witnessed a grand mal but can imagine the kind of human suffering these folks are trying to alliviate.

As Mir Imran suggests in the article the gap left over from what drugs serve may not be as wide as the startup would have hoped. I'd love to hear anyone weigh in with some numbers.

Jose Fernandez   2013-10-28 01:45:23

Interesting blog, I had to go back to neuropace webpage to see what kind of seizures they are targeting. Petit mal and grand mal, are not current used medical terms for seizures, the classification we use now are partial, generalized and unclassified. The target of these devices are Disabling motor simple partial seizures, complex partial seizures, and/or secondarily generalized seizures that are not controlled with the current medication.

I this will be something interesting specially for pediatric patients that have neurological syndromes that include these type of seizures and controlling that, could lead to a more healthy/regular style of life. Assuming this is only for adult patients, I am waiting to see what it will offer for the little ones.

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