Artrya Ltd (ASX:AYA) has received regulatory approval for its Salix Coronary Anatomy (SCA) product in Europe.
The European Notified Body (BSI) informed Artrya that the assessment for European CE Marking has been completed and they will recommend certification of the Salix V2.0 Software for marketing into Europe.
The scope of the assessment includes European EC certification in accordance with the European Medical Device Regulations 2017/745.
Marketing across Europe
This is an important milestone for Artrya as it now has permission to market the Salix software in 28 European Economic Area member countries.
The Conformite Europeenne Marking certifies that a product has met EU health, safety and environmental requirements, which ensure consumer safety.
“We are pleased to receive this significant regulatory approval for what is a substantial future market opportunity,’’ Artrya managing director and CEO John Barrington AM said.
The company continues to progress with the UKCA regulatory process, with Artrya passing two further assessment stages last quarter.
Artrya Salix is already listed on the Australian Register of Therapeutic Goods (ID 347719) and commercial release of SCA in Australia is planned for FY23.
On the basis of the Australian regulatory approval (ARTG 347719), the Salix Coronary Anatomy product received NZ Medsafe registration in July 2022. This will allow Artrya to commercialise the product in the New Zealand market.