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Synaptive Medical wins CE mark for neurosurgical planning system

Synaptive Medical has secured CE mark in Europe and regulatory approval in Australia for its BrightMatter Plan neurosurgical planning system.

The system can automatically generate tractography, which will allow surgeons to frame preoperative plans for less disruptive and accurate surgery.

BrightMatter Plan is a part of the company's solution, which is comprised of advanced imaging, informatics, surgical planning, navigation and robotic visualization with a digital microscope for brain surgery.

The neurosurgical planning system will automatically generate 3D and dynamic whole brain tractography through using diffusion tensor imaging, enabling to offer a complete picture of the white matter in the brain.

With the obtained information, BrightMatter Plan enables surgeons to explore multiple approaches for determining least invasive access point and safest route to the surgical target.

According to the company, the enhanced pre-surgical visualization will help to reduce complications and enable access to previously inaccessible brain locations.

Later, the resulting tractography and surgical plan can be shipped to navigation systems such as BrightMatter Guide for use in the operating room.

The neurosurgical planning system has already secured approval from the US Food and Drug Administration (FDA) and Health Canada.

Synaptive Medical 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 pre-operative planning needs.

“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.”

Image: BrightMatter Plan will automatically generate 3D and dynamic whole brain tractography through using diffusion tensor imaging. Photo: courtesy of Synaptive Medical.