FDA Clears Biospace's Revolutionary Low Dose Xray Imager
Biospace med announced that it has received 510k clearance from FDA to market EOS, a new digital Xray imager in the United States for 2D imaging use.
EOS 2D|3D technology is part of a total solution to orthopedic imaging allowing images to be obtained with a low dose of radiation and is capable of long length digital imaging, permitting full-body, uninterrupted digital imaging with a single scan. Information submitted to FDA in support of Biospace med's marketing application demonstrated up to 10 times reduction in dose when compared with commercially available film systems -- without compromising image quality.
Other features that set EOS apart from traditional Xray or Computed Tomography (CT) are:
-- Captures a full or partial body image
-- Large reduction in radiation dose
-- Multi-planar (frontal and lateral) images are obtained simultaneously in an upright, weight bearing position (unavailable in CT)
Whole body, standing position imaging is especially valued by orthopedic surgeons when examining spine and joint alignment, as it provides a more comprehensive clinical view.
"EOS represents an advancement in orthopedic imaging, integrating benefits previously unavailable in the marketplace," says Marie Meynadier, CEO of Biospace med. "Physicians will now be able to obtain accurate images while advancing the cause of lowering radiation dose to patients."
EOS is based upon a patented particle detector technology for which Georges Charpak received the Nobel Prize in Physics. Along with Charpak, Dr. Jean Dubousset, a world-renowned French pediatric orthopedic surgeon, also helped design EOS.
"The low dose, weight bearing images offer physicians a global view of the entire body and an understanding of the relationships that exist between joints," Dr. Dubousset said. "This insight into balance and posture can provide valuable surgical planning information and may reduce the need for higher dose exams."
EOS differs in several other respects from traditional film, digital Xray or CT. Its use of slot scanning technology eliminates vertical distortion that is common with traditional Xray systems. In addition, EOS enables long length digital imaging without the need for digital stitching -- all at a reduced dose. The simultaneous bi-plane image acquisition (front and side images acquired at the same time) eliminates the need for taking a second view and can save time.
According to a 2007 American College of Radiology study the benefits of diagnostic imaging are immense however, information gleaned from the International Commission on Radiological Protection has reported that CT doses can indeed approach or exceed levels that have been shown to result in an increase in cancer.
In addition, a June 19, 2007, New York Times article reported that the U.S. per capita radiation dose from clinical imaging exams rose by 600 percent between 1980 and 2006, with a major contributor being CT exams, whose numbers have increased over 20 times during this period.
The low dose benefits of EOS may be particularly useful for patients with spinal disorders, such as scoliosis, a spinal deformity condition affecting over 900,000 people in the U.S. alone. Scoliosis patients are typically required to undergo numerous radiographic exams to monitor progression of the disease as well as treatment effectiveness. A retrospective study of over 5,500 female scoliosis patients who received an average of 25 radiographs and whose initial diagnoses spanned a period of 50 years concluded that a statistically significant 70 percent excess risk of dying of breast cancer was observed compared to the general population.
"We are thrilled that the FDA has cleared EOS for the U.S. market after our many years of hard work and dedication," Meynadier added. "Providing physicians the EOS option for orthopedic imaging through both the Nobel Prize technology and the efforts of the entire team makes this a very exciting moment."