An AI model for prostate MRI offered an 89 percent AUC for prostate cancer detection in external validation testing, according to a newly published international multicenter study.
|Articles|December 13, 1995
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
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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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How will generative AI software be evaluated by the FDA in the future? What’s next for point-of-care ultrasound? What steps have been successful in facilitating adoption of AI applications across enterprise systems? Leaders in radiology and health care will be discussing these topics and more at the upcoming HLTH USA conference.
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Catch up on the top radiology content of the past week.
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