A U.S. Food and Drug Administration advisory committee last week voted unanimously that the premarket approval (PMA) application for a breast impedance imaging device be found "not approvable."
In an August 29 meeting, the FDA's Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee voted 10-0 to recommend a not approvable finding for the T-Scan 2000 ED device from Mirabel Medical Systems of Austin, TX.
The proposed indication for the device is as a complement to clinical breast examination (CBE) in asymptomatic women who are 30 to 39 years of age with a negative clinical breast exam and a negative family history for breast cancer, according to the FDA. The system detects electrical impedance changes in breast tissue that are associated with an increased risk of breast cancer.
The committee considered a clinical study that Mirabel conducted in which one arm assessed sensitivity by testing the device in women ages 30-45 with biopsy-proven cancer, and another arm assessed specificity by using the system in normal women ages 30-39.
In making its recommendation, the panel acknowledged that additional tools are needed for breast cancer screening. But the panel had concerns regarding device sensitivity, the size and population of the study, the number of cancers detected in study patients, and the risks associated with additional screening events.
By AuntMinnie.com staff writers
September 8, 2006
Related Reading
Mirabel Medical Systems, November 7, 2005
Electrical impedance imaging may identify younger women at risk for breast cancer, May 12, 2005
Mirabel raises $9 million, April 5, 2005
Road to RSNA, Mirabel Medical Systems, November 10, 2004
Copyright © 2006 AuntMinnie.com
