- ResApp is up as much as 40 per cent this morning after it announced that its first commercial product, ResAppDx-EU, received CE Mark certification
- This certification indicates that ResAppDx-EU meets all requirements of European regulations and can now be sold in the European Economic Unit
- ResAppDx-EU is a smartphone-based diagnostic test for acute paediatric respiratory disease
ResApp is one of the top gainers this morning, up 40 per cent at one point, after it announced its first commercial product, ResAppDx-EU, received CE Mark certification as a Class IIa medical device.
This CE Mark certification means ResAppDx-EU meets essential requirements of all applicable European regulations as a medical device, and allows for the sale of it in the European Economic Unit.
ResAppDx-EU is a mobile application to be used by clinicians for the diagnosis of lower respiratory tract disease, asthma, croup, and pneumonia in infants and children.
The software uses machine learning algorithms that analyse a patient’s cough sounds to diagnose diseases. ResAppDx-EU is a software-only solution that runs on an off-the-shelf smartphone and does not require additional hardware or accessories.
Today’s CE Mark approval was supported by data collected from ResApp’s Breath Easy paediatric clinical study. The study was a double-blind, prospective study which evaluated the effectiveness of ResApp’s product.
The study collected data from 58 patients and demonstrated that ResApp’s algorithms had excellent agreement with clinical diagnosis and results were published in the peer-reviewed journal ‘Respiratory Research’.
“We are very excited about receiving our first regulatory approval for ResAppDx-EU, our flagship acute diagnostic product,” Tony Keating, CEO and Managing Director of ResApp, said.
“For the first time clinicians in Europe will have access to a rapid and accurate diagnostic test for the most commonly seen acute respiratory conditions in children,” he said
ResAppDx-EU is the world’s first smartphone-based diagnostic test for acute paediatric respiratory disease.
“ResAppDx-EU has the potential to have far-reaching benefits in the healthcare system and we will now rapidly move ahead with our European commercialisation strategy,” Tony added.
This CE Mark certification will facilitate further regulatory submissions in Australia, Singapore, and Canada.
In April, ResApp submitted a De Novo classification request to the U.S. Food and Drug Administration which is currently pending review.
Shares in ResApp are trading for 20 cents apiece in a $104.4 million market cap.