No. Back in 2014, the FDA removed for clinical digital thermometers, which include smartphone-enabled, peel-and-stick temperature-sensing patches and the smartphone-connected thermometers*.
We simply need to meet the necessary quality requirements and register the product with FDA before we start shipping Check-my-Temp to you.* http://mobihealthnews.com/35378/fda-suggested-deregulation-affects-smart-scales-fertility-thermometers-some-iphone-connected-scopes/
Technically and legally speaking, we don't. We are working on advanced algorithms to accurately measure the temperature even in the presence of motion based on our patent-pending MultiTemp technology.
We want to clinically validate the algorithm so we can sleep peacefully at night knowing that we have delivered simply the best thermometer to our customers.
We began the clinical trials back in August 2015 and expect to wrap them up by Jan 2016.
We are obsessed about the user experience with Check-my-Temp, which is why we went through a complete redesign of the product (we are big fans of Steve Jobs). We are working on a few final hardware and software changes to ensure we provide only the best user experience.
On the hardware, we are trying to further reduce the overall size and weight so you can simply wear and forget about it after the first few minutes. We think 'Wear & Forget' is the key to success for any smart wearable device.
On the software, our current version of the app is fully functional but we are trying to fine tune it to get it just right.
We may need another 2-3 months to complete these activities before we move to mass production.
None at this time. With design and testing, we are quite encouraged with the preliminary results from the field trials. We plan to wrap up rest of the design & test activities in the next 2-3 months.
With regards to manufacturing Check-my-Temp, we do have experience with manufacturing precision electronic products. We have also added an industrial designer with medical product and FDA compliance expertise to help us navigate rapidly through the process.
We are confident in delivering Check-my-Temp with the highest quality to you soon.
As with any project, there may be a few glitches that may cause delays. We will provide you with regular updates on the overall progress and any unforeseen issues. You can count on that!
Check-my-Temp will support both IOS and Android devices. We will publish a list of all models on our website (www.checkmytemp.com) in the coming months.
Check-my-Temp sends the data in real time to a primary device (tablet or smartphone) via Bluetooth Low Energy radio. The primary device can in turn send the data wirelessly to the cloud. Once other devices are authorized to receive updates and alerts, you can start monitoring your loved ones remotely from your office or elsewhere.
The device can communicate via BLE to a smart device located up to 100ft/30m in the line of sight. Line of Sight refers to no walls or objects between Check-my-Temp and the smart device.
However, a typical house with walls and other objects will have an impact on the overall range. The actual distance may be shorter than 100ft (around 60-90 ft).
If you are experiencing issues with BLE range, simply have a smart device (phone or tablet) in the same room as the patient and switch to the Remote Monitoring mode.
We are very confident that our customers will love the product so we decided to offer a 100% money back guarantee.
If for some reason you don't like your Check-my-Temp, simply send it back to us and we will refund the full amount.
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