Cubresa Brain PET Scanner Receives FDA 510(k) Clearance, Integrates with Existing PET/MR Systems

Molecular imaging technology company Cubresa Inc. announced on August 20 that its Cubresa BrainPET™ scanner has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

According to the company, the Cubresa BrainPET™ is a positron emission tomography (PET) device specifically designed for brain imaging and can be integrated into existing Siemens Biograph mMR MR/PET systems. The device enables healthcare institutions to perform simultaneous PET/MR brain imaging on existing MRI infrastructure, capturing molecular and anatomical information without the need to purchase a separate whole-body hybrid imaging system.

Cubresa founder and CEO James Schellenberg stated that the FDA 510(k) clearance will advance the company's brain imaging technology into clinical application settings. By enabling simultaneous acquisition of molecular and anatomical images on existing MRI equipment, the technology can support clinicians in evaluating, diagnosing, and managing complex neurological diseases, including Alzheimer's disease and other dementias, epilepsy, and brain cancer.

The company noted that traditional whole-body PET/MR systems are typically costly and require substantial dedicated space. The Cubresa BrainPET™ features a low-profile design and can be used when simultaneous brain PET/MRI imaging is needed; when whole-body MRI examinations are required, the device can be removed to restore the MRI for those use cases. Cubresa stated that the product is aimed at clinical institutions seeking to expand their brain imaging capabilities.

Cubresa specializes in the design and development of PET insert devices for clinical and preclinical MRI systems. Its products help universities, hospitals, and pharmaceutical companies observe and measure biochemical processes at the molecular level, supporting precision medicine research and applications in fields such as neuroscience, oncology, and psychiatry.