ASX:AYAHealthcare Services
Did FDA Clearance for Real-Time Plaque Detection Just Shift Artrya's (ASX:AYA) Investment Narrative?
In August 2025, Artrya Limited announced it received 510(k) clearance from the U.S. FDA for its Salix® Coronary Plaque module, enabling real-time detection of high-risk coronary plaque and integrating with its existing Salix® Coronary Anatomy platform already used commercially in the U.S.
This regulatory milestone allows Artrya to expand its U.S. commercial launch, offer per-scan assessments reimbursed at the Category 1 CPT rate of US$950, and create new revenue streams for the...