Novocure filed a premarket approval (PMA) supplement application for its new, second generation Optune system with the U.S. Food and Drug Administration on Dec. 22, 2015. FDA approval of the PMA supplement is required before Novocure can make the improved Optune system available to glioblastoma patients in the U.S. Optune is a portable, noninvasive device that delivers Tumor Treating Fields (TTFields) therapy to patients with newly diagnosed and recurrent glioblastoma.

Novocure designed the second generation Optune system to improve the convenience and manageability of TTFields therapy for patients. The new model features a TTFields generator that is half the size and half the weight of the current system.