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1. Can Egoo produce the samme data quality as the blood tests my doctor orders?


Yes, our data is the exact same as you will get from your doctor. We work from whole blood just as your doctor does and there is no difference. We are regulated the same way and follow the same guidelines.




2. How come the Egoo tests are the same as my doctor will order?


Because the Egoo device is made in the same way as the big analysers in a central lab. The methodology, components, reagents and chemistries are the same and we use whole blood exactly like the big machines. Our achievement is to miniaturize it into a small box and then make it simple to use for anyone.




3. Does one capsule measure only one biomarker?


In principle yes, - because in order to keep the high quality of data, it is necessary to have enough blood. One drop of blood only provides enough volume to measure one biomarker at a high quality. In a few cases, like with CRP and HB it can measure both due to their connection to each other, but consider it a bonus.




4. Is Egoo a medical device?


Yes, Egoo is a medical device. And as such we live up to the same standards as all other devices used by your doctor. We are living up to all regulatory requirements in Denmark and the EU and we are getting all the required certifications needed.




5. Does Egoo follow regulatory guidelines?


Yes, absolutely. Egoo follows the EU IVD regulations for self-testing. Devices for self-testing must be designed and manufactured in such a way as to “ensure that the device is easy to use by the intended user, reduce the risk of user error in the handling of the device and in the interpretation of the results, and must, where reasonably possible, include user controls, i.e. a procedure by which the user can verify that, at the time of use, the product will perform as intended.”

Furthermore, Egoo is ISO13485 certified, a high standard quality seal for medical devices. This ISO standard certifies the ability of an organization to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. ISO certification is valid worldwide.

For more info go to our regulatory page <- turn into link




6. Is Egoo FDA approved for marketing in the USA and what about Asia and the rest of the world?


No, not yet. Regulatory pathways differ in different countries, so we must live up to each individual country regulatory guidelines to sell the product in that country. However, as a guideline when the product is certified in the EU and FDA approved in the USA we can roll-out in most countries, each country processes becomes more a registration process. However, for a country like China for instance, here we also may be stuck in regulatory activities for some time before we can launch into this market.




7. How does Egoo handle data privacy?


Your data is strictly private to you. We understand that medical data is extremely sensitive and therefore our system is structured so that we cannot access your data. We just provide a structure to store it in the cloud and share it if you approve it, with e.g. your doctor.

On top of this we follow all applicable guidelines such as ISO 27001/2 and the EU GDPR guideline. In some projects related to a specific disease the data is tied to a national database for that specific disease, here data protection rules are even tougher.




8. Can the data be communicated to my doctor, clinic or hospital?


Yes. Through the Egoo Cloud the data can be shared with any ICT system (e.g. medical records, doctor local IT systems or other databases.




9. How do I get the small amount of blood that Egoo uses?


Egoo capsules come with a finger stick that you use on your fingertip to take 1-2 drops of blood. The blood is collected into a small capillary and disposed into the blood unit in the capsule. After that everything is done automatically.




10. Has Egoo been validated in clinical trials?


Yes, we have run several clinical and usability studies. As part of our regulatory processes in the EU it is necessary to run studies to include for each biomarker a technical file which is either self-certified or approved by the local Notify Body. All this data has validated the premise of Egoo.





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EGOO.HEALTH

Borupvang 3

DK-2750 Ballerup

Denmark

CVR 39982277

info@egoo.health