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 of IDE trials published along with their economic analyses using the cervical total disc replacement device versus traditional anterior cervical discectomy and fusion as control to educate healthcare providers about the basic terminology and practical concepts behind the complex statistical jargon and calculations. Healthcare economics is currently very important in reimbursement as well as planning medical treatment. As this paper simplifies and improves our understanding of these complex interlinked processes, it is a must read for us all.

Understanding United States Investigational Device exemption studies – clinical relevance and importance for healthcare economics.
Ament JD, Mollan S, Greenan K, et al.
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Gauri Mankekar

Department of Otolaryngology-Head Neck Surgery, Louisiana State University Shreveport, Louisiana, USA.

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