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FDA Clears New Features in AI-Powered Mammography Software Suite

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Therapixel’s MammoScreen suite has received 510(k) FDA clearances for a breast density assessment feature and updated software that includes automated pre-reporting, which reportedly expedites reporting of mammography findings.

A new version of an AI-enabled mammography software may enhance breast cancer detection and bolster workflow efficiency for mammography assessment.

Therapixel’s updated MammoScreen suite has garnered new 510(k) clearances for breast density evaluation and new software that offers a variety of features to help reduce workflow bottlenecks for radiologists.

FDA Clears New Features in AI-Powered Mammography Software Suite

Therapixel's updated MammoScreen mammography suite garnered a new FDA 510(k) clearance for breast density assessment and clearance of new software, which includes automated pre-reporting that facilitates enhanced efficiency with reporting of mammography findings. (Image courtesy of Therapixel.)

The company said key features include the ability to organize the day’s worklist through a case complexity index; an algorithm that facilitates assessment of 2D and 3D breast imaging and a patient’s prior history; and automated pre-reporting that facilitates enhanced efficiency with reporting of mammography findings.

“With these new features, radiologists can double their reading time savings compared to the previous version. Radiologists will appreciate the reduced fatigue, administrators the improved efficiency and care consistency, and the IT team the seamless one-time installation. We’re proud to launch this new version of MammoScreen, once again delivering unparalleled value to radiologists and patients,” noted Matthieu Leclerc-Chalvet, the chief executive officer of Therapixel.

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