Need to write a paper describing the evidence of safety and effectiveness of a stimulator for depression (medical device)
The assignment for the paper is to provide a written summary describing why stimulator (medical device) is safe and effective in VNS therapy system in depression only
it should have 4 pages excluding references and cover page, AMA format only, plagiarism free
The paper should cover the following areas:
Description of device and indication
Safety summary: “Why does FDA consider this device to be safe? What measurement was used and why is it clinically meaningful?”
Effectiveness/efficacy summary: “Why does FDA consider this device to be effective? What measurement(s) was/were used and why is it clinically meaningful?
Summary of peer-review publications/evidence. Do subsequent published reports replicate the data in the SSED? What new information was learned?