All test required for commercialisation of child version to CE & EEU countries have been completed hence the submission, unquestionably great results and the adult testing won’t be far away.
Your original question of “how does CE equate to revenue” has been answered, However proper market saturation will only be achieved with approvals for child and adult in place across the globe.
If a country is approved to use a product that greatly benefits the inhabitants, saving massive amounts of time and money for governments/patients the question is “why wouldn’t the Telehealth companies operating in those areas sign a non exclusive agreement “??
The preparation and filing of the CE Mark Technical File for ResAppDx-EU, our flagship acute respiratory disease diagnostic tool, is an exciting moment for ResApp as it unlocks the last element required to commercialise our first product,” said Tony Keating, CEO and Managing Director. “Europe represents a very attractive opportunity with a large portion of the continent’s six billion annual general practitioner visits related to respiratory disease. ResAppDx-EU will provide clinicians with the first rapid and accurate test for the most commonly-seen acute respiratory diseases. It has the potential to have far-reaching benefits for the healthcare system and we are working with a German private hospital network this European winter to quantify these benefits.”
ResApp plans to file a De Novo premarket submission for its acute paediatric respiratory disease diagnostic smartphone application with the US Food and Drug Administration in the first quarter of this calendar year.
ResApp has two other major clinical programs underway; an acute adult respiratory disease diagnosis study in which clinical adjudication is expected to finish this quarter and an at-home obstructive sleep apnoea study in which recruitment is nearly complete. As announced previously, a technical issue prevented clinical adjudication for croup in ResApp's acute paediatric respiratory disease diagnosis study in the US, SMARTCOUGH-C-2, however this has been resolved and adjudication is expected to be completed this quarter.
I think the results were good....
https://hotcopper.com.au/documentdownload?id=uOMxKKzFkiWRTLKhOROKAxjvTDYD4wi6wBWZsvZpke92GA==
