INVENTIVE PRODUCTS SENSOR PAD NEEDS CLINICAL TRIAL TO GAUGE POTENTIAL "MASKING"
This article was originally published in The Gray Sheet
Executive Summary
INVENTIVE PRODUCTS SENSOR PAD NEEDS CLINICAL TRIAL TO GAUGE POTENTIAL "MASKING" effect, FDA's Obstetrics and Gynecological Devices Advisory Panel said at a Sept. 1 meeting in Rockville, Maryland. The panel concluded that devices intended to aid women in breast self-examination (BSE) should undergo clinical trials to determine whether they might "mask" or prevent detection of breast cancer. Although the panel's recommendation applies to all BSE aids, the only specific device discussed at the meeting was the Sensor Pad.