Synaptive’s BrightMatter Plan secures CE mark and Australian regulatory approval

24 April 2017 (Last Updated April 24th, 2017 18:30)

Canada-based company Synaptive Medical has secured European CE mark and Australian regulatory approval to market its BrightMatter Plan.

Synaptive’s BrightMatter Plan secures CE mark and Australian regulatory approval

Canada-based company Synaptive Medical has secured European CE mark and Australian regulatory approval to market its BrightMatter Plan.

BrightMatter Plan is a neurosurgical planning system designed to automatically generate dynamic tractography, allowing easy preoperative planning for less disruptive and more precise surgery.

The system employs an advanced MRI, diffusion tensor imaging, to generate a 3D dynamic whole brain tractography of white matter in the brain.  

Synaptive president and co-founder Cameron Piron said: “Europe and Australia are home to many highly influential clinician-researchers in neurosurgery.

"We look forward to opportunities to collaborate and understand their preoperative planning needs.

"We anticipate that BrightMatter Plan will be the first of many Synaptive products to receive regulatory approval to support better outcomes for patients in Europe and Australia."

“We anticipate that BrightMatter Plan will be the first of many Synaptive products to receive regulatory approval to support better outcomes for patients in Europe and Australia.”

A part of the firm's solutions of advanced imaging, informatics, surgical planning, navigation and robotic visualisation with a digital microscope for brain surgery, BrightMatter Plan enables surgeons to explore various approaches to establish the least invasive access point and safest route to the surgical target.

The increased visualisation provided by the system is expected to mitigate complications and allow access to previously inaccessible brain locations.

The generated tractography and surgical plan can be used in the operating room using navigation systems such as BrightMatter Guide.

BrightMatter Plan has also obtained approval from the US Food and Drug Administration (FDA) and Health Canada.


Image: BrightMatter Plan by Synaptive Medical automatically generates 3D, dynamic whole brain tractography. Photo: courtesy of Synaptive Medical.