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The following was taken off the news wire. Does anyone follow this company? Wednesday May 21 1:30 PM EDT Breast "Thermometer" to be Marketed NEW YORK (Reuters) -- A new device aimed at improving the detection of breast tumors will go on sale in the U.S. next month. The BreastAlert Differential Temperature Sensor is to be marketed by HumaScan Inc. According to a statement from the company, the device may "improve chances for detection of fast-growing... tumors in the intervals between mammographic screenings." The device, which consists of two mirrored pads that use chemical sensors to detect changes in breast temperature, was approved by the Food and Drug Administration in 1984, but was not developed for sale until now. HumaScan licensed the technology from the inventor, Dr. Zgsimond Sagi, in 1995. "When early-stage breast cancer is present, metabolic activity increases, producing excessive heat which most often escapes at the surface of the breast," according to a statement issued by HumaScan last December. "The BreastAlert device records skin temperatures on three large areas of each breast... alerting the physician to possible underlying breast disease in need of further examination." The BreastAlert is used by inserting it into the bra for 15 minutes before a clinical breast exam by a physician. The device changes color to indicate a rise in temperature, which can indicate the presence of a tumor, explained Donald Brounstein, HumaScan's president and CEO. HumaScan officials do not know whether the device will be covered by insurance, but say that Cigna and Oxford Health Plans have asked to participate in ongoing, larger clinical trials. Insurance coverage could be in doubt, however, as the Medicare program in 1984 ruled that thermography was not a valid diagnostic screening tool for breast cancer. And in 1993, the American Medical Association said that it wouldn't recommend thermography for diagnostic purposes. Brounstein emphasized to investors that BreastAlert is not a diagnostic, but an "adjunctive screening" device. HumaScan Inc. officials told investors at the Cruttenden Roth Health Care conference on Monday that the company will begin selling the device in the Northeast by the end of June. The Cranford, New Jersey-based firm plans to begin selling the BreastAlert device nationally by October. | ||||||||||||||
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