FDA Panel Applauds Maestro Weight Loss Device, Despite Efficacy Shortfall
This article was originally published in The Gray Sheet
An advisory panel voted in support of EnteroMedics’ Maestro Rechargeable System, despite the device’s failure to meet its primary effectiveness endpoints. The implantable device is intended to stimulate the vagus nerve to achieve weight reduction in obese patients.
You may also be interested in...
Asking whether FDA’s decision to allow emergency use of two old anti-malarial drugs was ‘political’ misses the point. The issue already was political, and FDA’s action may well be the best way to keep some measure of federal control on supplies of a drug with important other uses.
Guidelines for health care providers could help prevent shortages as demand for possible treatments surge, groups say. Stakeholders also argue “Buy America” executive order would hamper drug access.
BD and BioMedomics have released a new rapid point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19.