What's interesting here is that the FDA's own panel of experts, which reviews both medical devices and drugs for either approval or denial, had initially recommended that the FDA approve this device. But in a last minute change, someone higher up in the FDA blocked the approval, going against the full recommendation of the FDA's own panel of experts. This is something that rarely happens.
Executives at Cyberonics have their theories for why this device may have been blocked for approval by the FDA, but I have my own theory: electromedicine competes with prescription drugs. If a device can stimulate the nerve of a depressed patient and give them effective treatment, then that patient very likely won't need to be taking prescription drugs like Prozac and Paxil. And there's no recurring revenue in an electrostimulating device -- a patient buys it once, and from that point forward, treatments are essentially free, because electricity is virtually without cost.
Prescription drugs, on the other hand, are very expensive and must be taken over and over again -- sometimes for a lifetime -- by patients who believe the advice of their doctors. Therefore, the FDA denied approval of this device in order to protect the profits of the pharmaceutical industry, which of course seems to be the primary mission of the FDA based on agency actions we have observed over the past several years. That's not a new idea, either -- more and more critics are speaking out against the FDA, and noting that the FDA seems far more interested in protecting the profits of Big Pharma than protecting the health of the public.
Clearly, if an electrostimulating device could safely help patients with depression, it would be in the interest of public health to approve it. It would also be a financial benefit to people if they could buy a device with a one-time payment rather than shelling out monthly payments for overpriced prescription drugs. Again, this is only my theory, but I think that is precisely why the FDA blocked the approval of this device, and I have little doubt that executives from Cyberonics, Inc. privately agree with this assessment.