The ResApp Health Ltd (ASX: RAP) share price has been a strong performer on the ASX on Friday.
In late morning trade the digital health company's shares have rocketed 30% higher to 19.5 cents.
Why is the ResApp share price rocketing higher?
Investors have been fighting to get hold of the company's shares this morning after the release of a positive announcement.
According to the release, the company's first commercial product, ResAppDx-EU, has received CE Mark certification as a Class IIa medical device.
This CE Mark certification means that ResAppDx-EU meets the essential requirements of all the applicable European regulations as a medical device and allows for the sale of ResAppDx-EU in the European Economic Area.
What is ResAppDx-EU?
ResAppDx-EU is the world's first smartphone-based diagnostic test for acute paediatric respiratory disease.
It can be used by clinicians for the diagnosis of lower respiratory tract disease, croup, pneumonia, asthma/reactive airway disease and bronchiolitis in infants and children. The software uses machine learning algorithms that analyse a patient's cough sounds to diagnose disease.
One key selling point is that it is a software-only solution that runs on an off-the-shelf smartphone and does not require any additional hardware or accessories.
The company's CEO and managing director, Tony Keating, was very pleased with the news.
He said: "We are very excited about receiving our first regulatory approval for ResAppDx-EU, our flagship acute diagnostic product."
"This is our biggest achievement yet and results from many years of hard work by our dedicated team. 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. 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," Mr Keating added.
Looking ahead, the company believes that this CE Mark certification will facilitate further regulatory submissions in Australia, Canada and Singapore. Its De Novo classification request in the United States is currently pending review.
Also rising strongly today in the industry is the Mayne Pharma Group Ltd (ASX: MYX) share price. It has bounced back from a decline at the open to be up 11% at the time of writing. Elsewhere, the high flying CSL Limited (ASX: CSL) share price has edged lower with the rest of the market.
