ATL's HDI Digital Ultrasound Is Approved for Breast Indication

May 1, 1996

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.

BOTHELL, Wash--A High Definition Imaging (HDI) digital ultrasoundsystem from Advanced Technology Laboratories (ATL) has been grantedFDA approval for a new indication--adjuvant use with mammog-raphyand physical examination to help physicians determine if a biopsyis necessary after discovery of a suspicious breast lesion.

The indication for the Ultramark 9 HDI system is based on thefindings of an international multicenter study involving morethan 1,000 women with breast lesions who were undergoing breastbiopsy.

Lesions were classified based on mammography results, then reclassifiedafter an HDI ultrasound examination performed before breast biopsy.

Investigators found that the number of biopsies could be reducedby approximately 40% using ATL's HDI ultrasound system to distinguishbenign from malignant lesions that were indeterminate by mammographyand physical examination.