BOTHELL, Wash--A High Definition Imaging (HDI) digital ultrasound
system from Advanced Technology Laboratories (ATL) has been granted
FDA approval for a new indication--adjuvant use with mammog-raphy
and physical examination to help physicians determine if a biopsy
is necessary after discovery of a suspicious breast lesion.
The indication for the Ultramark 9 HDI system is based on the
findings of an international multicenter study involving more
than 1,000 women with breast lesions who were undergoing breast
Lesions were classified based on mammography results, then reclassified
after an HDI ultrasound examination performed before breast biopsy.
Investigators found that the number of biopsies could be reduced
by approximately 40% using ATL's HDI ultrasound system to distinguish
benign from malignant lesions that were indeterminate by mammography
and physical examination.