NOVEMBER 25, 2008--Imaging Diagnostic Systems (Fort Lauderdale, FL), developer of laser optical breast imaging systems, has announced the issuance of its 21st US patent, "Apparatus and Method for Acquiring Time-Resolved Measurements Utilizing Direct Digitization of the Temporal Point Spread Function of the Detected Light."
The invention, conceived by Steven Ponder Ph.D., Imaging Diagnostic Systems' Director of Advanced Development; and Robert Wake, Vice President of Engineering, covers a key technology for time-resolved optical imaging that improves the quality of the imaging data and decreases the time required to acquire the image data. It exploits a long-established trend in integrated circuit evolution to advance the acquisition of time-resolved image data for optical imaging of human and animal subjects.
"This invention exploits recent advances in the speed of digital acquisition components in order to reduce the cost and complexity of time-resolved measurement systems," said Dr. Ponder. He explained, "Time-resolved CTLM imaging of the breast can provide quantitative information that may be used to discriminate between malignant and benign lesions. However, the technique is inherently more time consuming than our standard continuous wave Computed Tomography Laser Mammography (CTLM) scanning method, and it requires sophisticated and expensive circuitry to make accurate measurements of the very short pulses of light used in time-resolved imaging."
The invention also promises to reduce the costs of what has been an otherwise prohibitively expensive technology, namely efficient time-resolved optical imaging, whether computed tomography or topography.
Imaging Diagnostic Systems designed its new CTLM imaging device to aid in the detection and management of breast cancer. The system uses laser technology and patented algorithms to create 3-D images of the breast. The procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or painful breast compression. CT Laser Mammography (CTLM) is designed to be used in conjunction with mammography in detecting breast cancer in the dense breast patient population, which is not commonly detected with mammography alone.
Imaging Diagnostic Systems is currently collecting data from clinical sites for the future filing of an FDA Premarket Approval (PMA) for the system to be used as an adjunct to mammography. The FDA has determined that the company's clinical study is a non-significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States. It has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.
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