FDA Clears Cubresa BrainPET, a Dedicated Brain PET Insert for MRI

FDA cleared Cubresa BrainPET, a dedicated brain positron emission tomography (PET) insert for MRI systems, via 510(k) pathway. The device is intended for functional brain imaging.

• FDA clearance via 510(k) pathway, product code OUO (positron emission tomography system, brain).
• The Cubresa BrainPET is a dedicated insert designed to enable simultaneous PET/MRI brain imaging.
• No specific performance metrics were disclosed in the clearance announcement.

Automated summary

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