Artrya Ltd (ASX:AYA) has passed a key milestone with the medical technology company receiving regulatory approval for its Salix Coronary Anatomy (SCA) product in the United Kingdom.
The Perth-based company has been notified by the European Notified Body (BSI) that the assessment for UKCA Class 2 Certification has been completed and they will recommend certification of the Salix V2.0 Software for marketing into the United Kingdom.
BSI’s assessment scope includes UKCA certification in accordance with the UK Medical Devices Regulations 2002 and Artrya’s Salix AI Coronary Software met or exceeded all regulatory requirements.
“Landmark moment”
Artrya managing director and CEO John Barrington AM said UK regulatory approval was a landmark moment for the company.
“Our business activities in the UK are advanced and Artrya is well positioned to take advantage of the regulatory approval in this significant market," he said.
Once the UKCA certificate has been issued by BSI, Artrya is able to market the Salix software in the UK.
Managing director and CEO John Barrington AM.
“Biggest market opportunity”
Artrya already has a four-year contract in place to supply 1,250 National Health Service Trust Hospitals throughout the UK with the SCA product.
The company is now able to approach these hospitals to finalise arrangements for the product rollout.
“This is Artrya’s biggest market opportunity to date and we aim to take full advantage of it," Barrington said.
Other business development activities in the UK are well advanced for use of the SCA product within clinical practices outside of the National Health Service network.
About Artrya
Artrya was founded in 2018 and began operations in early 2019. The company is listed on the Australian Securities Exchange.
The applied artificial intelligence healthcare company works alongside clinicians to improve the diagnosis of coronary heart disease and develop a holistic overview of a patient at risk.
The company has developed deep learning algorithms that will allow for the prediction and prevention of acute coronary events.