FDA Approves Transducer Array Layout System for Use in Patients With Recurrent Glioblastoma Multiforme
Novocure recently announced that it has received FDA approval for its NovoTAL (Transducer Array Layout) System through a Premarket Approval supplement. The NovoTAL System allows certified physicians to use the individual magnetic resonance imaging data of recurrent glioblastoma multiforme patients to optimize the field distribution and intensity of tumor treating fields (TTF) therapy.
The NovoTAL System is a workstation-based software tool that uses MRI head morphology, tumor size and location measurements, and tissue dielectric properties to optimize tumor treating field distribution and intensity within the brain tumor.
In 2011, the FDA approved Novocure’s NovoTTF-100A System, a noninvasive medical device that produces a low-intensity, alternating electric field within a tumor, resulting in malignant cell death. The device is approved in the treatment of adult patients aged 22 and older with histologically confirmed glioblastoma multiforme, following confirmed recurrence in an upper region of the brain after receiving chemotherapy. ■