Palpagraph uses mechanical arm for breast palpationA newly established medical technology firm is developing a noninvasive breast tumor detection technology that it hopes will provide a way to detect tumors missed by mammography. UltraTouch of
Palpagraph uses mechanical arm for breast palpation
A newly established medical technology firm is developing a noninvasive breast tumor detection technology that it hopes will provide a way to detect tumors missed by mammography. UltraTouch of Paoli, PA, hopes this year to submit its system to the Food and Drug Administration for expedited review.
UltraTouchs product is called Palpagraph and employs a computer-controlled electromechanical device to detect and map breast tumors using mechanically driven palpation rather than x-rays. The device consists of a bed with a small mechanical arm that includes one or more palpation fingers. The patient lies face up on the bed, and the diagnoser head is placed above the breast tissue to measure the resistance to the pressure placed on breast tissue by the mechanical fingers. Using neural network data processing techniques, the device creates a grid of several thousand points and compares each points pressure measurements.
Data gathered by Palpagraph is displayed on a video monitor and is manipulated in three dimensions, according to Dr. Jeff Garwin, president of UltraTouch. The device can image to the chest wall, and produces data that define a suspicious items position horizontally and vertically. The exam takes about 20 minutes and requires little compression.
This device was designed to mimic what is actually done in a good manual palpation by a physician, except it doesnt get distracted and (it produces data that can be stored electronically) from one year to the next, Garwin said.
Palpagraph was invented in the early 90s by Iranian scientist Farid Souluer while he was associated with the University of Rehabilitation in Tehran. In 1994, the system was tested in Iran on about 800 women ranging in age from 22 to 75. Approximately 30% of the women had received mammograms before being tested with Palpagraph. Palpagraph detected 22 tumors, ranging from 2 mm to 9 mm.
Souluer came to the U.S. in 1997 and applied for a patent for Palpagraph, which is still pending. He and Garwin founded UltraTouch in October. The emerging company is developing Palpagraph as a breast cancer detection tool rather than a diagnostic device, Garwin said.
Because mammography is so well established as the gold standard, I think its unrealistic to expect that Palpagraph will replace mammography anytime soon, Garwin said. But it could be used for high-risk cases, for younger women, or for women with dense breast tissue.
UltraTouch has just begun the regulatory process for Palpagraph and believes the device will require premarket approval, due to its novelty. Gaining expedited review will help speed the process, however. The firm expects to submit an application to the FDA within three years.
UltraTouch isnt the only firm seeking to develop an electronic breast palpation device. Assurance Medical of Needham, MA, a subsidiary of medical product manufacturer UroMed, has received expedited review status from the FDA for its electronic handheld device. Assurances progress can only help UltraTouchs efforts to obtain clearance, according to Garwin.
We believe that since (Assurance) already has expedited review for their unit, well be able to get expedited review for ours, he said.
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