Evidence requirements for innovative imaging devices: from concept to adoption.

@article{Frank2011EvidenceRF,
  title={Evidence requirements for innovative imaging devices: from concept to adoption.},
  author={Richard A Frank and Donald Rucker and Michael A. J. Ferguson and Terry J Sweeney},
  journal={Journal of the American College of Radiology : JACR},
  year={2011},
  volume={8 2},
  pages={124-31}
}
Changes in the regulatory and reimbursement environment for advances in imaging in the United States are leading to increasing requirements for formal clinical evidence of efficacy, effectiveness, and safety. The authors describe 5 phases of an imaging product's lifecycle: design, regulatory clearance and approval, early adoption, reimbursement, and full… CONTINUE READING

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