No it is not. Medical grade implies a compliance with certain standards and certification which are different from country to country and even industry to industry. While Dotty has taken steps to validate the devices effectiveness and accuracy it needs to be made clear that this is not designed for diagnosis. It can provide a real-time early warning system where a medical grade alternative isn’t available. All results should always be followed up with a medical secondary screening.

Dotty has added an optional FDA bluetooth thermometer from Comper available here. This provides a single button secondary screening option which informs the app of the reading, and access will be granted within the apps settings.   

 

Dotty is in the process of applying for a Class 1 device certification in Australia via the Therapeutics Goods Association & we will update the community when this is granted.