General Electric, Siemens Healthcare USA and Philips Healthcare
An article in the February 2011 issue of the Journal of the
American College of Radiology provides a road map for imaging manufacturers
to navigate the increasingly complex US regulatory and reimbursement environment.
“Evidence Requirements for Innovative Imaging Devices: From Concept to Adoption”
addresses the five phases of an imaging procedure’s life cycle and the distinct
clinical evidence needs for each phase. It examines the design, regulatory clearance
and approval, early adoption, reimbursement and full clinical adoption of imaging
technology. The article is co-authored by Richard Frank, vice president of global
clinical strategy and policy at General Electric; Donald W. Rucker, chief medical
officer of Siemens Healthcare USA; Michael A. Ferguson, global director of clinical
outcomes and translational research at Philips Healthcare; and Terry J. Sweeney,
senior vice president of corporate quality and regulatory affairs at Philips Healthcare.
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