Imaging Diagnostic Systems has submitted a Premarket Notification (PMN) 510(k) to the US Food and Drug Administration (FDA) for its breast imaging device, Computed Tomography Laser Mammography (CTLM) system.
The CTLM system is a breast imaging device intended to aid in the diagnosis of breast cancer in a non-invasive procedure and it uses laser technology, proprietary computed algorithms instead of x-rays and breast compression to create three-dimensional views of the blood supply in the breast.
IDSI said that the images can be used to complement current breast imaging modalities, providing additional information on the nature of breast abnormalities.
Imaging Diagnostic Systems CEO Linda Grable said that this submission is a significant step toward the realization of our dream of marketing this unique breast imaging device throughout the US.
"CTLM has the potential to be an addition to breast imaging facilities, especially in difficult cases, like patients with dense breasts. We are committed to getting this product to market as quickly as possible, while simultaneously developing strong distribution channels and marketing resources for its launch," Grable said.