NexStim wins Health Canada approval for NBS, NexSpeech

Nexstim said today that it won approval from Health Canada for its NBS system and NexSpeech devices. The Helsinki-based company’s NBS system and NexSpeech comprise a diagnostic device intended for the non-invasive localization of the brain areas that control motor and speech functions. The devices are used by neurosurgeons for surgical planning prior to brain tumor operations or in treating treatment-resistant epilepsy, Nexstim said. Both the NBS system and NexSpeech use navigated Transcranial Magnetic Stimulation to better allow for personalized, accurate and reproducible stimulation of specific areas of the brain, the company said. Nexstim said that it has already inked a distribution agreement with a Canadian distribution company to bring both systems to the market in the region, according to a press release. Earlier this week, Nexstim said that it won FDA 510(k) clearance for a new, shorter treatment protocol for its Navigated Brain Therapy transcranial magnetic stimulation system intended to treat major depressive disorder. The post NexStim wins Health Canada approval for NBS, NexSpeech appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Neurological Regulatory/Compliance Nexstim Source Type: news