Synaptive Medical said today that it won CE Mark clearance in the European Union and regulatory approval in Australia for its BrightMatter Plan neurosurgical planning system.
The Toronto-based company’s technology automatically generates 3D pictures of the brain, allowing surgeons to craft accurate preoperative plans.
“Europe and Australia are home to many highly influential clinician-researchers in neurosurgery. We look forward to opportunities to collaborate and understand their pre-operative planning needs,” co-founder & president Cameron Piron said in prepared remarks. “We anticipate that Plan will be the first of many Synaptive products to receive regulatory approval to support better outcomes for patients in Europe and Australia.”
The company’s technology uses diffusion tensor imaging to create a complete picture of the brain, enabling surgeons to determine the least invasive access point and safest route for a given operation, according to Synaptive.
The pre-surgical planning system may help reduce complications and could help surgeons access previously inaccessible regions of the brain, Synaptive added.
“This is a key year for our international expansion as Synaptive scales up in global healthcare markets,” Piron said. “Expanding our presence in the UK, Ireland, Germany, Switzerland, the Nordic countries, Singapore, and Australia is another step toward bringing Canadian innovation to the world.”
Synaptive’s BrightMatter Plan has also won approval by the FDA, Health Canada and TGA.