Prescient Imaging Gains 510(k) Clearance for Portable PET Scanner
Hawthorne, Calif.-based Prescient Imaging has received 510(k) clearance from the FDA for its portable positron emission tomography (PET) scanner BBX-PET.
The device, which can be wheeled to the point of care, is cleared for obtaining PET images of parts of the human body, including the head. Potential uses include scans in neurology, geriatric psychiatry and radiation oncology centers.
The mobile scanner can be used to help diagnose Alzheimer’s disease, according to Michael Rafii, medical director of the Alzheimer's Therapeutic Research Institute at the University of Southern California.