Cubresa Announces FDA 510(k) Clearance for the Cubresa BrainPET™ Scanner, Opening New Frontier in Clinical Brain Imaging
WINNIPEG, MANITOBA, CANADA, August 20, 2026 /EINPresswire.com/ -- Cubresa Inc., a global leader in clinical and
Press Release Disclaimer: This is a press release distributed through the XPR Media network. It has not been independently verified by our newsroom.
WINNIPEG, MANITOBA, CANADA, August 20, 2026 /EINPresswire.com/ — Cubresa Inc., a global leader in clinical and preclinical molecular imaging technologies, today announced that it has received FDA 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking Cubresa BrainPET™ scanner.
The Cubresa BrainPET™ is an innovative, dedicated Positron Emission Tomography (PET) scanner designed to retrofit seamlessly into existing Siemens Biograph mMR MR/PET devices. This allows medical institutions to perform simultaneous, high-resolution PET/MR brain imaging without the massive capital expense of buying a standalone, whole-body hybrid system.
“FDA 510(k) clearance is a transformative milestone for Cubresa, bringing our world-class brain imaging technology directly into frontline clinical settings,” said James Schellenberg, PhD, Founder and CEO of Cubresa. “By enabling simultaneous molecular and anatomical scanning on existing MRI infrastructure, we are empowering clinicians to better evaluate, diagnose, and manage complex neurological conditions including Alzheimer’s disease and other dementias, epilepsy, and brain cancers.”
A Paradigm Shift in Neuroimaging Performance & Accessibility
Traditional whole-body PET/MR scanners are cost-prohibitive and require extensive, dedicated space. Cubresa’s BrainPET changes the paradigm with a low-profile design at a much lower price point. The Cubresa BrainPET™ scanner delivers excellent image quality when simultaneous PET/MRI of the brain is needed but can be removed to enable whole-body MRI imaging when required. The Cubresa BrainPET is a powerful tool for clinical sites looking to expand their brain imaging capabilities.
About Cubresa Inc.
Cubresa is a world leader in the design and development of clinical and preclinical PET inserts for MRI. Cubresa’s products enable medical professionals at leading universities, hospitals, and pharmaceutical companies to visualize and measure biochemical processes at the molecular level, advancing precision medicine in neuroscience, oncology, and psychiatry. For more information, visit www.cubresa.com.
Lisa Bako
Cubresa Inc
+1 204-798-4579
email us here
Visit us on social media:
LinkedIn
Legal Disclaimer:
EIN Presswire provides this news content “as is” without warranty of any kind. We do not accept any responsibility or liability
for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this
article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
Media gallery
