Developers of portable PET scanner devices to seek FDA approval

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Developers of portable PET scanner devices to seek FDA approval

John W. Mitchell, Senior Correspondent | June 19, 2017
Molecular Imaging PET
Prescient Imaging’s unusual PET scanner designs generated quite a bit of interest in the SNMMI exhibit hall.

“Our goal is to have portable PET scanners that can be moved out of the nuclear medicine department to where the patients are – whether it’s in the Interventional Radiology, ICU, NICU, OR, or in a nursing home.” According to Mike Mesenbrink, executive VP at Prescient Imaging.

The company showed off its investigational vertical PET scanner ring for use with patients who can remain upright; easier for patients with congestive heart failure, chronic pulmonary obstructive disease, obesity or claustrophobia. Mesenbrink also said their scanner has a smaller footprint and lower weight than existing PET-CT scanners.

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President and chief scientist Farhad Daghighian, Ph.D. said that once the FDA begins approving its devices – and the first is to be submitted soon - Prescient Imaging will define the sector with scanners that are protected by issued and pending patents.

“We are the future of the market, not a niche,” he told HCB News. “This is the next frontier in PET imaging.” New medical procedures will be developed rising from this technology.

Prescient Imaging has five models of innovative PET scanners in the product development pipeline to help meet the needs of a wide array of physicians, from neurologists, interventional radiologists, radiation oncologists, and cardiologists, to surgeons.

Daghighian also said the machines are ideal for the emerging field of “Theranostics” (i.e.; therapeutic and diagnostic at once), in which nuclear tracers are used to guide treatment in real time. They are also working with Atheron Corp. to use Prescient’s intra-operative PET scanner (P-Arm) together with an intra-ventricular positron detector for use in such procedures as delivery of stem cells to a damaged myocardium.

Prescient Imaging’s PET scanners include:

Vertical PET: is designed to improve cardiac PET imaging. By allowing the patient to sit upright, they can stress their cardiovascular system using a stationary bike within the scanner field. Imaging can commence directly within the scanner field of view. The ring scan raises and lowers to facilitate loading patients, which accommodates throughput.

BBX Organ-Specific PET: This unit is designed for scanning the brain, breasts, and extremities –without compression. The unit weighs 300 pounds for easy transport.

P-Arm: The scanner is designed for interventional application, similar to an X-ray or C-arm. Because one set of detectors is placed under the patient and one above, it provides a 360-degree coverage around the patient.

Biopsy PET DX: This unit is portable with a small footprint, it is intended to image tissue samples. It can be used in the pathology lab or
surgical suite to image samples removed from a patient.

PET-Xtend: This unit is designed to be light and narrow to bring PET capability to the 85,000 CT and MRI scanners currently in operation. It is placed between the table platform and a CT scanner, for example. The images from the CT are loaded into the PET-Xtend’s computer for fusion with the PET image.

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