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.
What are the primary CADScor®System studies?
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Feb