ClearPoint Neuro Announces ANVISA Approval of Neuro Navigation Portfolio in Brazil
Saturday, April 15, 2023
ClearPoint Neuro, Inc., a global therapy-enabling platform company providing navigation and delivery to the brain, today announced successful registration of its Neuro Navigation portfolio with the Brazilian regulatory body, Agência Nacional de Vigilância Sanitária (ANVISA).
“I have had the opportunity to see the ClearPoint Neuro Navigation System in action several times and was thrilled to hear that it has been finally approved by Brazil’s regulatory agency,” stated Raquel Rodrigues, MD, M.Sc, Pediatric Neurosurgeon and Neuro-oncologist in Brazil. “With a very intuitive interface and software, I personally believe it’s easy to manage its features, even for a neurosurgeon only trained in traditional neuro navigation methods. With ClearPoint we plan, for the very first time in Latin America, to offer to our patients unprecedented medical treatments, such as Convection Enhanced Delivery (CED) for brain cancer and neurodegenerative disorders with intra-procedural MRI guidance. Furthermore, with this system we hope to refine our DBS implants, deep brain biopsies and laser ablations. I am honored to lead the neurosurgical team that will perform the first neurosurgery with this splendid technology here in Brazil.”
“We are incredibly proud to have obtained ANVISA approval after an extensive review,” explained Megan Faulkenberry, Vice President of Quality at ClearPoint Neuro. “Our first approval in Latin America is an important milestone supporting our 4th growth pillar: international expansion. Each global approval we attain helps us and our pharmaceutical partners to provide new therapies, both clinically and in clinical trials, for patients with some of the most devastating neurological disorders.”