Australian medical technology company Artrya (ASX:AYA) has received regulatory approval for its Salix Coronary Anatomy (SCA) product in the UK.
The European Notified Body (BSI) has informed Artrya 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 UK.
Once the UKCA certificate has been issued by BSI, Artrya is able to market the Salix software in the UK.
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.
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,’’ added Mr Barrington.