FDA awards clearance to first portable PET scanner
The U.S. Food and Drug Administration has granted clearance to a portable positron emission tomography scanner, according to a July 26 announcement.
Hawthorne, California-based Prescient Imaging gained the 510(k) clearance for its BBX-PET machine and says it is the first and only device of its kind.
Farhad Daghighian, PhD, CEO and co-founder of the company said the scanner can be wheeled into a physician’s office, hospital room, nursing homes, and other settings to deliver point-of-care service. The portable device also scans at higher resolutions and at lower costs, Daghighian added.
“[The] BBX-PET scanner is intended to obtain PET images of parts of the human body that fit in the patient aperture (e.g., head) to detect abnormal pattern of distribution of radioactivity after injection of a positron-emitting radiopharmaceutical,” the chief executive explained Monday. “This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.”
Prescient is owned by Daghighian along with private investors who have chipped in more than $8 million to develop the portable PET scanner, according to the company.