Prescient Imaging LLC Receives FDA Clearance for First Portable PET Scanner
Prescient Imaging LLC announced today that it has received 510k FDA clearance for its portable Positron Emission Tomography (“PET”) scanner: BBX™-PET.
Prescient Imaging LLC, a California-based company, over the last seven years has developed the first and only portable PET scanner cleared for use by the U.S. Federal Food and Drug Administration.
The Indication for Use of the BBX-PET Scanner is stated as:
“BBX™-PET scanner is intended to obtain positron emission tomography (PET) images of parts of the human body that fit in the patient aperture (e.g., head) to detect abnormal patterns of distribution of radioactivity after injection of a positron-emitting radiopharmaceutical. This information can assist in research, diagnosis, therapeutic planning, and therapeutic outcome assessment.”
In addition to hospitals and imaging centers, Dr. Farhad Daghighian, CEO and co-founder of the
Prescient Imaging LLC, explained: “We expect our scanners provide unparalleled opportunities for growth in neurology, geriatric psychiatry, and radiation oncology centers. In addition, BBX-PET scanners provide higher resolution than conventional PET scanners and at a lower cost.”
The most important feature of BBX-PET scanners is that they are portable and can be wheeled to the point-of-care in a physician’s office, a hospital room, ER, OR, or nursing homes, explained Mr. Patrick Laverty, CEO of Modern Nuclear Inc., a provider of mobile imaging services in California. The logistical advantage of BBX-PET will greatly expand the availability of this vital imaging modality.
“PET imaging of the brain is essential to the accurate diagnosis of Alzheimer’s disease”, according to Michael Rafii MD, Ph.D., Associate Professor of Neurology at the Keck School of Medicine of the University of Southern California. “As new therapeutics become available for the treatment of Alzheimer’s Disease, accurate diagnosis will be critical before initiation of any disease-modifying therapy.”
Prescient’s scanners incorporate the claims of three issued and two pending U.S. patents for which the company owns or has exclusive licenses, as well as other proprietary technology.
The market for conventional PET scanners is in the billions of dollars per year given their complex and multimillion-dollar installation cost. Prescient’s portable scanners, however, open an entirely new and larger market, at a lower cost.
Prescient is owned by its co-founder Dr. Farhad Daghighian and private investors who have invested over $8,000,000 in the development of the BBX-PET scanner.
For more information about the investigational devices described here or on becoming an investigator please contact:
Farhad Daghighian, PhD
President & Chief Scientist
Prescient Imaging, LLC
12569 Crenshaw Boulevard
Hawthorne, California 90250
Phone: (844) 426-627