Clinical Studies and Research
Acarix Clinical Development Program
The clinical program behind CADScor®System is comprehensive, with the Adopt CAD, BIO-CAC and Dan-NICAD clinical studies with 2,591 patients forming the basis for CE marking and FDA De Novo clearance. Overall, the clinical studies include 8,000 patients, of which 6,800 are in the clinical development program. Additional studies are underway to further strengthen the performance metrics and the algorithm and expand the product portfolio.
Key Clinical Publications
CADScor®System is a point-of-care diagnostic aid that uses highly sensitive acoustics and advanced computational processing to analyze the patient's coronary blood flow. The system calculates a patient-specific CAD-score, and couples it with risk factors to rapidly indicate the patient’s risk of significant coronary stenosis for immediate risk stratification, prior to potential secondary evaluation.1 CADScor®System has been used in over 29,000 patient assessments 2 and has CE-marking and FDA De Novo clearance.
- User manual US-FDA v.12.Y, prevalence 10,7%
- Based on commercial patch use since 2017