Journal Reviews

Healthcare economics and device approvals

9 October 2017 | | Cervical total disc arthroplasty, Clinical trial design, Noninferiority, Randomized controlled trial, Statistical review, Superiority

We use several FDA-approved devices in our clinical practice but are rarely aware about the stringent procedures followed by manufacturers, as well as the FDA, before the devices become commercially available. The authors of this paper undertook a comprehensive review...