FDA to hear ATL's breast ultrasound PMA
A Food and Drug Administration advisory committee was scheduledto meet Dec. 11 to discuss ATL's premarket approval (PMA) applicationfor using ultrasound to differentiate benign from malignant breastlesions. If the PMA is approved, it could represent a
A Food and Drug Administration advisory committee was scheduledto meet Dec. 11 to discuss ATL's premarket approval (PMA) applicationfor using ultrasound to differentiate benign from malignant breastlesions.
If the PMA is approved, it could represent a major step inthe expansion of ultrasound in breast imaging. ATL hopes thatthe use of its HDI technology for differentiating breast ultrasoundlesions could reduce the need for breast biopsy by 35%.
ATL, of Bothell, WA, filed the PMA in February 1994 (SCAN 1/19/94).The application received fast-track review status from the FDA,leading the company to hope that it would be approved that year.The filing has languished at the agency since then, however.
At Monday's meeting, the FDA committee was scheduled to discussthe PMA and recommend whether the agency should approve it. TheFDA typically acts on advisory committee approval recommendationswithin several months after they are issued.
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