Cubresa wins FDA clearance for BrainPET brain scanner

Cubresa Inc. said Aug. 20, 2026, it won FDA 510(k) clearance for its BrainPET scanner, a device designed to add dedicated brain PET imaging to existing Siemens Biograph mMR systems. The clearance could broaden access to simultaneous PET/MR brain scans for hospitals and clinics treating neurological disease.

Why it matters: - The FDA clearance opens a new clinical path for simultaneous PET/MR brain imaging without requiring sites to buy a standalone whole-body hybrid scanner. - The BrainPET system is aimed at conditions where better brain imaging can affect diagnosis and management, including Alzheimer's disease, other dementias, epilepsy and brain cancers. - The lower-capital retrofit approach could make advanced neuroimaging more accessible for hospitals and imaging centers.

What happened: - Cubresa Inc. announced it received FDA 510(k) clearance from the U.S. Food and Drug Administration for the Cubresa BrainPET scanner. - The announcement came Aug. 20, 2026, from Winnipeg, Manitoba, Canada. - Cubresa described BrainPET as a dedicated Positron Emission Tomography scanner designed to retrofit into existing Siemens Biograph mMR MR/PET devices. - The company said the system enables simultaneous, high-resolution PET/MR brain imaging on existing MRI infrastructure.

The details: - BrainPET is designed as a low-profile insert for brain imaging rather than a whole-body hybrid scanner. - The scanner can be removed when a site needs whole-body MRI imaging. - Cubresa said the design delivers excellent image quality for clinical sites that need brain PET/MRI. - The retrofit approach avoids the large capital expense and dedicated space requirements tied to traditional whole-body PET/MR scanners. - Cubresa positions the product as a tool for expanding brain imaging capabilities at clinical sites. - Founder and CEO James Schellenberg said the clearance marks a transformative milestone for the company. - Schellenberg said the system enables clinicians to better evaluate, diagnose and manage complex neurological conditions.

Between the lines: - The clearance suggests Cubresa is pushing PET/MR technology from a specialized research setting toward broader clinical use. - A retrofit product can be easier for hospitals to adopt than a full system replacement, especially where MRI infrastructure already exists. - The announcement also signals competition around cost, flexibility and space in advanced neuroimaging.

What's next: - Cubresa is now positioned to market BrainPET to clinical sites looking to add dedicated brain PET capability. - Adoption will likely depend on hospital purchasing decisions, workflow fit and the pace of installation into compatible Siemens systems. - The company says more information is available at Cubresa's website. - Cubresa also listed its LinkedIn page at the company's social media profile.

The bottom line: - FDA clearance gives Cubresa a regulatory green light for a retrofit brain imaging system that could lower the barrier to advanced PET/MR scanning.