Artrya Wins European Approvals Despite FDA Rejection
Despite failing to garner U.S. approval, Australian devicemaker Artrya has nabbed regulatory approvals in both the EU and UK to market its Salix CT scan analysis software for identifying arterial plague build-up that can cause coronary artery disease.
The company claims the image analysis software is unique since it requires no external reading teams to validate cardiac scans, preventing unnecessary hospitalization and diagnosis of patients with non-critical disorders while more quickly zeroing in on patients at risk of heart attack.
Artrya announced approval to market the device in EU countries on Oct. 27 and a little over a week later revealed it received authorization from the UK’s Medicines & Healthcare Products Regulatory Agency.
But the company’s 510(k) application to the FDA was rejected in June, marking a rare moment of regulatory discord among the world’s top health regulatory agencies.