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ATL's HDI Digital Ultrasound Is Approved for Breast Indication

ATL's HDI Digital Ultrasound Is Approved for Breast Indication

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 biopsy.

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.

 
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