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

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 ...

2026-08-22

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