OGDEN, Utah, April 16 -- Computerized Thermal Imaging, Inc. reports that its subsidiary, Thermal Medical Imaging, Inc. (TMI) has received approval from the US Food and Drug Administration (FDA) to file a Modular Pre-Market Approval Application for its Thermal Breast Imaging System. This Approval Application was recently adopted by the FDA in order to facilitate the review and approval process for new medical devices.
TMI's system for the detection of breast cancer uses a heat sensitive camera to record thermal images of breast tissue. These images are then processed with a proprietary computer algorithm designed to recognize the distinct heat signatures of benign and malignant tissue. A proposed alternative to mammograms and clinical examination, the test is simple, painless and requires no exposure to radiation or breast compression.