Cyberonics plans PMA (premarket approval) for depression device:
This article was originally published in Clinica
Cyberonics says it will submit a premarket approval (PMA) application to the US FDA at the end of October for its implantable device for treating depression. The announcement follows successful preliminary talks with the agency. The VNS Therapy device, which stimulates the vagus nerve, in under expedited review and Houston, Texas-based Cyberonics expects the FDA to approve the device within one year. The therapy is aimed at improving symptoms in patients with treatment resistant depression.