• AI
  • Molecular Imaging
  • CT
  • X-Ray
  • Ultrasound
  • MRI
  • Facility Management
  • Mammography

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
Employing AI in Detecting Subdural Hematomas on Head CTs: An Interview with Jeremy Heit, MD, PhD
Pertinent Insights into the Imaging of Patients with Marfan Syndrome
What New Brain MRI Research Reveals About Cannabis Use and Working Memory Tasks
Current and Emerging Legislative Priorities for Radiology in 2025
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 2
A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Phillip Kuo, MD, Part 2
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 1
A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Phillip Kuo, MD, Part 1
Teleradiology and Breast Imaging: Keys to Facilitating Personalized Service, Efficiency and Equity
Current and Emerging Insights on AI in Breast Imaging: An Interview with Mark Traill, MD, Part 3
Related Content
© 2025 MJH Life Sciences

All rights reserved.