SYDNEY, Australia--(BUSINESS WIRE)--Omniscient Neurotechnology (“o8t™”), a pioneering brain mapping software company, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Quicktome™, a digital brain mapping platform that allows neurosurgeons to visualize and understand a patient's brain networks prior to performing life-changing brain surgery. This announcement occurs on Glioblastoma Awareness Day, a day dedicated to increasing public understanding of the most common, complex, treatment-resistant, and deadliest type of brain cancer.
In addition to FDA clearance in the United States, Quicktome has also received Health Canada approval as well as regulatory clearance by the Therapeutic Goods Administration (TGA) of Australia.
Quicktome is a neurosurgical planning software which incorporates “connectomics”, the field of understanding brain connectivity, into routine neurosurgical planning. Critically, by visualizing networks that are responsible for complex functions such as language, movement, and cognition, Quicktome assists neurosurgeons in making more informed decisions and reduces surgical uncertainty.
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Utilizing cloud computing for large-volume data processing, and intuitive browser-based interfaces, Quicktome aims to streamline the process for neurosurgeons. The digital platform furthermore enables multidisciplinary collaboration in hospitals, and greater insight on a patient before and during surgery.
“We are thrilled to receive regulatory clearance for Quicktome. This is the first digital mapping platform designed to incorporate brain connectome data for neurosurgeons to improve patient outcomes,” said Stephen Scheeler, CEO, Omniscient Neurotechnology. “Until now, the tools that neurosurgeons have relied on have been no match for the brain’s complexity. Quicktome breaks information down into actionable insights to inform the impact each incision will have on the patient. Since its authorization, physicians are already relying on this technology to guide surgical planning. This is a significant milestone for Omniscient and, more importantly, begins a new era for neurosurgery for patients and physicians.”
“I wish I had technology like this when I started practicing,” said Dr. Michael Sughrue, Chief Medical Officer, Omniscient Neurotechnology, a neurosurgeon who has completed over 3,000 brain tumor removals. “When I learnt about connectomics, I realized the biggest impact I could make to the field of neurosurgery was to make Quicktome a routine source of insight for all neurosurgeons. With this ground-breaking technology, our hope is for a better quality of life for patients and families after brain surgery."