After a long, tortuous, at times maybe even hopeless, wait, coughing app maker ResApp (ASX:RAP) finally has something to truly celebrate: its device has been approved for use in Europe.

The company announced today that ResAppDx-EU, a smartphone-based diagnostic test for acute paediatric respiratory disease, had received CE Mark certification as a Class IIa medical device.

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RAP shares jumped 47 per cent to 22c on the news, their highest point since October last year. Shares have fluctuated between lows of 6.9c and highs of 28c over the past year as the company has sweated on the outcome of US and European applications.

While approval from the US Food and Drug Administration (FDA) still awaits, ResApp employees and shareholders can now breathe a sigh of relief, as ResAppDx-EU can be sold in the European economic area, at least for acute paediatric respiratory disease.

ResApp has several other indications for which it is hoping its device can be used as a diagnostic tool, including lower respiratory tract disease, asthma and reactive airway disease, and primary upper respiratory tract disease.

“We are very excited about receiving our first regulatory approval for ResAppDx-EU, our flagship acute diagnostic product,” said Tony Keating, CEO and managing director.

“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.”

In other ASX health news today:

MGC Pharma (ASX:MXC) wants medicinal cannabis patients to be allowed to drive. Currently, they cannot under Australian law, but the company hopes to change that. It has received ethics approval to run a trial assessing the effects of its epilepsy drug CannEpil on driver performance.

Matt Callahan, of Botanix (ASX:BOT) and Orthocell (ASX:OCC), taking time off. Callahan, a director of both Botanix and Orthocell, is taking a leave of absence from both companies for personal reasons. He will return to the board of both when ready.

Next Science (ASX:NXS), Patrys (ASX:PAB) and OncoSil (ASX:OSL) report results. Next Science saw revenue rise by 222 per cent but loss widen by 10 per cent. Patrys’ revenue rose 62 per cent and loss narrowed by 84 per cent. OncoSil is treading water, revenue falling 16 per cent and loss largely the same.

At Stockhead, we tell it like it is. While MGC Pharma is a Stockhead advertiser, it did not sponsor this article.

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