Approval from FDA to File 'Modular Pre-Market Approval Application' for its Thermal Breast Imaging System
OGDEN, Utah, April 15 /PRNewswire/ -- Computerized Thermal Imaging, Inc. announced today that its subsidiary, Thermal Medical Imaging, Inc. (TMI) has received approval from the FDA to file a Modular Pre-Market Approval for its Thermal Breast Imaging System.
"I'm excited to begin the formal FDA approval process. Use of the Modular PMA process allows us to begin submitting information and start the dialog necessary to address the many details of the FDA approval process much earlier than would otherwise be possible,'' said David Packer, President of TMI.
The FDA's "Modular Pre-Market Approval Application'' has been recently adopted by the Agency in order to facilitate the review and approval process of new medical devices. The essence of a modular concept for data development, submission, review, and closure is to break the contents of a PMA into well-delineated components and to have reports of each component submitted as soon as the sponsor has performed the testing and analyses. This would a allow more rapid closure when the last components are submitted because much of the review work will already have been completed.
TMI is seeking approval for the Thermal Breast Imaging System as an adjunctive diagnostic test to mammogram and clinical examination for the detection of breast cancer. The system is currently undergoing multi-center clinical trials to test its efficacy in differentiating benign from malignant breast abnormalities. The system uses a sophisticated 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. The test is simple, painless and requires no exposure to radiation or breast compression.
The worldwide market for safe and effective adjunctive test for breast cancer could reach $2 billion within a few years of market introduction. Industry sources indicate that a cost-effective examination with the demonstrated ability to correctly identify malignant lesions would rapidly gain market acceptance, as it would save the healthcare system millions of dollars in benign biopsy costs. An average breast biopsy currently costs $2,000, with 70%-80% of breast biopsies yielding benign results.
Computerized Thermal Imaging, Inc. develops and deploys thermal imaging and associated technologies for use in the enhancement of medical screening, diagnosis and patient management. More information about CTI can be found on the Internet at www.cti-net.com or by calling CTI Public Affairs at (801) 776-4700.
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