- Artrya (AYA) receives regulatory approval for its Salix Coronary Anatomy (SCA) product in the United Kingdom from the European Notified Body (BSI)
- The BSI found that the company’s Salix V2.0 software had met or exceeded all regulatory requirements and has recommended the software for marketing into the UK
- With the new approval, Artrya is now able to approach hospitals as part of its four-year contract with the SCA product to finalise arrangements for the product roll out
- Shares in Artrya end the day 3.03 per cent in the red to close at 64 cents
Australian medical technology company Artrya (AYA) has received regulatory approval for its Salix Coronary Anatomy (SCA) product in the United Kingdom.
The European Notified Body (BSI) informed the company that the assessment for UKCA Class 2 certification is complete and the software had met or exceeded all regulatory requirements.
The recommendation by the BSI is certification of the Salix V2.0 software for marketing into the UK.
Managing Director and CEO John Barrington 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.
“This is Artrya’s biggest market opportunity to date and we aim to take full advantage of it.”
Currently, the company has a four-year contract in place to supply 1250 National Health Service (NHS) Trust Hospitals throughout the UK with the SCA product.
With the new approval, Artrya is now able to approach these hospitals to finalise arrangements for the product roll out.
The company said other business development activities in the UK are well advanced for use of the SCA product within clinical practices outside of the NHS network.
Shares in Artrya ended the day 3.03 per cent in the red to close at 64 cents.