http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/EarNoseandThroatDevicesPanel/UCM194431.pdf
This is the information from Envoy Medical about the Esteem device that has been posted on the FDA website. It has information about the clinical trials, specific device specifications, and risks. This site goes into great detail about the clinical trials. The FDA would post the information about the science of the trials and the statistics.
This is not such an easy read, it is 42 pages of pure information that is quite an overload for the mind. If you don't have a background or some kind of experience in science you would easily get confused reading this article.
No comments:
Post a Comment