Hybridyne Imaging Technologies Receives FDA Clearance for New Medical Imaging System

Hybridyne Imaging Technologies, Inc., a developer of compact, high-resolution gamma cameras for the detection of cancer and other abnormalities in the body, announces FDA clearance of ProxiScan™. 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. Terry Lall, Hybridyne’s President and CEO proudly said, “ProxiScan™ is the first gamma camera to receive FDA clearance for endocavity imaging.”

The unique 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. “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,” said co-developer Dr. Yonggang Cui of Brookhaven.

ProxiScan™ is also capable of high-performance imaging of radiopharmaceuticals distributed within anatomical regions of interest located close to the camera head. “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,” said Dr. Ralph B. James, a senior scientist at Brookhaven and another co-developer of ProxiScan™.

Improved images of radiopharmaceuticals could have a huge impact in several medical applications. “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,” said Dr. Youngho Seo, a faculty member at the Department of Radiology and Biomedical Imaging at University of California, San Francisco.

ProxiScan’s™ portability, performance and low cost are important features for its use at medical facilities for the diagnosis and treatment of some diseases. Dr. Ken Weisman, a urologist with CT Surgical, Hartford, Connecticut said, “We are very 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,” Lall said. Future products will target application-specific clinical uses of its technology to address areas where the small gamma camera is expected to have a major impact.