Dilon Technologies Inc. has submitted its Dilon 2000 gamma camera to the Food and Drug Administration for 510(k) approval.
Gamma cameras are categorized by the FDA as Class I devices, allowing approval prior to clinical trials. Dilon is seeking approval as a general purpose small field-of-view gamma camera suitable for a variety of high-resolution applications. The FDA is expected to take about three months for the 510(k) approval.
"We are excited about entering this stage of development," said F. Lon Slane, president and CEO of Dilon Technologies Inc. "Once we obtain FDA approval, we can begin to bring the product to market."
The targeted first use for the Dilon 2000 gamma camera is as a non-invasive breast imaging device in performing scintimammography procedures. Scintimammography is a nuclear medicine technique that images the metabolic activity of breast lesions.
Dilon has licensed the technology for the Dilon 2000 high-resolution, digital gamma camera from Southeastern Universities Research Association and the U.S. Department of Energy's Thomas Jefferson National Accelerator Facility under a Cooperative Research and Development Agreement. This technology was originally developed by Jefferson Lab's detector group for use in its nuclear physics mission. With the assistance of Jefferson Lab, Dilon is developing the technology into a commercial product for use in medical imaging.
Submitted: Friday, January 1, 1999 - 1:00am