[57] FDA explains that the MAUDE database is a passive surveillance system, and that incidence, prevalence, or cause of an event cannot be determined from this surveillance system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use
Improved Lipid and Glucose Regulation : In experimental settings, AOD-9604 has been observed to improve lipid metabolism and glucose tolerance , supporting better insulin sensitivity and reduced circulating cholesterol levels
Because the new technology service was not separately paid in this scenario, the overall number of single claims available to determine an appropriate clinical APC for the new service was reduced
Vegetarians, especially teenage girls who are not as nutrition savvy, may also suffer
Allen S