FDA to hear ATL's breast ultrasound PMA

Article

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.

Recent Videos
Study: MRI-Based AI Enhances Detection of Seminal Vesicle Invasion in Prostate Cancer
What New Research Reveals About the Impact of AI and DBT Screening: An Interview with Manisha Bahl, MD
Can AI Assessment of Longitudinal MRI Scans Improve Prediction for Pediatric Glioma Recurrence?
A Closer Look at MRI-Guided Adaptive Radiotherapy for Monitoring and Treating Glioblastomas
Incorporating CT Colonography into Radiology Practice
What New Research Reveals About Computed Tomography and Radiation-Induced Cancer Risk
What New Interventional Radiology Research Reveals About Treatment for Breast Cancer Liver Metastases
New Mammography Studies Assess Image-Based AI Risk Models and Breast Arterial Calcification Detection
Can Deep Learning Provide a CT-Less Alternative for Attenuation Compensation with SPECT MPI?
Employing AI in Detecting Subdural Hematomas on Head CTs: An Interview with Jeremy Heit, MD, PhD
Related Content
© 2025 MJH Life Sciences

All rights reserved.