FDA 510(k) Clearance for the Cubresa BrainPET™ Scanner

WINNIPEG, MB — August 20, 2026 — 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.

Media Contact: Lisa Bako
VP Sales and Strategic Partnerships
Phone – 1.204.798.4579
Email: Lbako @ Cubresa.com