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I am pregnant now, so devices like this are highly relevant to me. This sounds great, however I am wondering how accurate it is. Electronic thermometers are class II FDA devices, and so should be approved by the FDA as such. However, I can't find on their website that it is approved, which is an issue with most of these techie monitoring devices (movement monitors, booties etc). They are registered as consumer electronics, and made without proper clinical trials, therefore, they are basically electronic toys.
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@ghromis Hi Gabriela, not all health thermometers need to be FDA cleared. Also under the S. 510 predicate process "clinical trials" as that term is commonly understood is not required, even for class II devices. Pacif-i falls within the new draft guidance published by the FDA on general wellness devices where FDA clearance is not required if the device represents low risk. Pacif-i is no less accurate than an FDA certified device because of us making the decision to fall within that guidance. Pacif-i is lab certified for FCC and CSPSC purposes. Look not at what certification the device carries, but the stated manufacturer accuracy.
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@kirstinhancock@ghromis There is no such thing as "a baby smart device not needed to be checked by the FDA ", Especially the baby products. The rubber could be toxic, the electronic device inside could be radiating, or easy to extract and swallow by a baby, and since you took so much time to explain why you went around the FDA approval, something is suspicious here, you really took an defensive stance on that one. Would you put some unknown device in your childs mouth if it was unchecked for health, radiation and safety issues ? Didn't think so.
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@edinvejzovic@ghromis Baby products do need to be checked by the FDA. They certainly need to comply with safety standards (as Pacif-i does) and this may require testing for toxicity and the like (as Pacif-i has been).
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@kirstinhancock@ghromis Glad it's that way, in that case , best of luck with the project. I missunderstood it from the comment :) .
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low level persistent radiation in a soft tissue cavity during development? interesting...but finding lost binkies - priceless!
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Interesting to see the responses here concerning FDA approval and bluetooth exposure. I feel like there's an opportunity for a 'compliance' service provider in this space. Especially after the ongoing Theranos debacle.
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@shloky With ever more connected devices using Bluetooth technology becoming available on the market for parents and babies, a key question on every parent’s mind is “could this Bluetooth device be harmful to my baby?” Here is a blog I posted that will give you more information http://pacif-i.io/blogs/news/792...
This makes me wonder... as a parent of 2, with both of them using/used pacifier, I can see two issues with this product :
1. Kids loose their pacifier when they sleep. The monitoring system will fail at that moment, and trust me, it happens often, really often!
2. Pacifier are supposed to be changed every 2/3 months. (at least in France, but it's just a recommandation, you can keep it for 12 years if you want ...). Paying 55$ every 2/3 month is ... well ... :p
3. Since it is recommended to first clean the pacifier by putting it in boiling water for at least 5 minutes, is the Pacif-i ready for that kind of stress?
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@kirstinhancock Hi Kirstin, Love the tempo btw! Is the disc usable for monitoring cold chain products under MHRA GDP?
Being a father of 2 young kids who have been babies within the last few years, I see a few issue with this. First, neither of my kids really used pacifiers. Amongst my circle of friends, I'd say a little less than half of the babies are/have been pacifier users.
Secondly, even if your baby uses a pacifier, they don't always want to suck on one, especially when they're in a bad mood (i.e. when they're sick, which would be a common use case for this). We've always used ear thermometers that are highly accurate, take 2 seconds, and doesn't require a newborns or toddlers cooperation (it also scales for use beyond the pacifier stage). Bluetooth emanating from my babies head is also a little worrisome. As for post-medication temp monitoring, I don't really feel that's a problem that needs solving. Again, 2 seconds with an ear scanner 10m after giving medication would more than suffice.
I know it's my own opinion, but especially in this space, I feel like technology isn't always the answer. Common sense, education, and good old fashion parenting is not only enough, but often times better.
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@wuss Not all babies take a pacifier, but statistically 70% do. And evidence shows that when babies are ill they are more inclined to suck on a pacifier than when they are healthy. Pacif-i is quicker in taking a temperature than an in-ear thermometer since if the baby has had it in their mouth for a few minutes the reading is almost instantaneous. Plus you don't have to disturb them by attempting to put something in their ear, which can be distressing for them if they are also suffering ear-ache which can happen sometimes. In terms of Bluetooth waves, the signal is so weak (less than 1% of an iPhone 5) that if the baby is in the same room as a WiFi router they will be exposed to many more times the radio emissions from the router than the Pacif-i in their mouth. It is also worth noting the Bluetooth chip is located at the very front of the device, so is always about 10mm outside the mouth of the baby. Nothing beats common sense and good old fashioned parenting for sure, but sometimes new technologies such as Pacif-i can make parenting that little bit easier.
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