Evidence Requirements for Innovative Imaging Devices: From Concept to Adoption

摘要: Changes in the regulatory and reimbursement environment for advances imaging United States are leading to increasing requirements formal clinical evidence of efficacy, effectiveness, safety. The authors describe 5 phases an product's lifecycle: design, clearance approval, early adoption, reimbursement, full adoption. Each phase has distinct needs evidence. With costs generation, question ownership responsibility gather at each successive becomes important. Mismatch between pace technologies time required do trials clear threatens patient access benefits innovation such as reduction exposure radiation. Public payer must also be evaluated their impact on incremental design improvements, which have historically characterized diagnostic imaging.