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FDA Clears HIT New Medical Imaging System

Hybridyne Imaging Technologies (HIT), a developer of compact, high-resolution gamma cameras for the detection of cancer and other abnormalities in the body, has received FDA clearance for its ProxiScan, a new gamma camera that is used for diagnosis of cancer.

The system can be used in imaging the distribution of radionuclides in the human body using planar imaging techniques. ProxiScan may also be used intra-operatively, on pathological specimens and for endocavity applications if a protective sheath is used.

The component of the technology is a small cadmium zinc telluride (CZT)-based compact gamma camera developed by Hybridyne in collaboration with scientists at Brookhaven National Laboratory.

HIT said that the ProxiScan’s portability, performance and low cost are important features for its use at medical facilities for the diagnosis and treatment of some diseases. ProxiScan is also capable of high-performance imaging of radiopharmaceuticals distributed within anatomical regions of interest located close to the camera head.

Ralph James, a senior scientist at Brookhaven and another co-developer of ProxiScan, said: “Brookhaven’s pre-clinical laboratory experiments demonstrated the high-spatial-resolution and high-contrast capabilities of the instrument. Images of shaped phantoms have shown spatial resolutions as low as 1-2 millimeters, potentially allowing more precise information about the distribution of radionuclides in nuclear medical applications.”

Youngho Seo, a faculty member at the department of Radiology and Biomedical Imaging at University of California, San Francisco, said: “There is a widespread need for better nuclear-medical images in cancer diagnosis. ProxiScan, when coupled with a suitable radioactive tracer, has the potential to detect smaller lesions than conventional Anger cameras.”

Yonggang Cui, co-developer of Brookhaven, said: “The compact size of the instrument allows placement of the camera close to the objects of interest, thus creating the possibility of reductions in the radiation dose to patients.”

Ken Weisman, an urologist with CT Surgical, Hartford, Connecticut, said: “We are excited about the potential use of compact digital camera systems to improve our ability to localize and treat cancer. For example, active surveillance has become an increasingly popular option. In contrast to historical radical surgery, both active surveillance and focal therapy are either non- or minimally-invasive, but better imaging tools are desperately needed to monitor the progression of the disease.

“ProxiScan delivers high performance in a small package at a much lower cost than conventional nuclear medical instruments. It offers significant advances for imaging small regions with the uptake of a radiopharmaceutical regions that might simply be missed by other imaging systems with lower resolution.”