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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 Pacif-i falls within the new draft guidance published by the FDA on general wellness devices where FDA clearance is not required if the device represents low risk.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 :) .
@casielane Hi Casie, I invented Pacif-i when my youngest was very sick. I could not take her temperature using conventional methods available, I researched the market and couldn't find anything that could do what I needed! So I made the life changing choice to set up Blue Maestro.
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I'm friends with one of the ladies involved with this project..very proud!
I am a mother of 3, love the idea ! this is so complicated when the child is sick...
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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...
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