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 AI to analyze the patient's coronary blood flow.¹ In just 10 minutes, it calculates a patient-specific CAD-score, indicating the patient’s risk of coronary stenosis. CADScor®System has been used in 20,000 patient assessments² and has CE-marking and FDA De Novo clearance.
- Therming, C. et al. Low Diagnostic Yield of Non-Invasive Testing in Patients with Suspected Coronary Artery Disease: Results From a Large Unselected Hospital-Based Sample. Eur Heart J – Qual Care Clin Outcomes 2018: 4, 301-308
- Winther, S. et al. Diagnostic performance of an acoustic-based system for coronary artery disease risk stratification. Heart 2018: 104, 928-935