U-Systems’ Breast Screening Tool Receives FDA Panel Recommendation for Approval: WMIS Thrilled About the Development

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FDA Panel has recommended the approval of U-Systems’ Automated Breast Ultrasound System.

FDA Panel has recommended the approval of U-Systems’ Automated Breast Ultrasound System. While the recommendation for approval does not automatically imply that the approval will be granted, FDA does generally follow the recommendations of its panels.

U-Systems’ ABUS tool is used for women with dense breasts – a population segment of more than 1/3rd of the women in the United States. If approval is granted, U-Systems’ ABUS will become the approved device used as an adjunct to mammography for breast cancer screening in women with dense breast.

In many cases mammography alone cannot always detect cancer in women with dense breasts. Integrating a 3D ultrasound test with the existing tests can increase the likelihood of detecting cancer that may go undetected otherwise.

WMIS welcomes the development as it introduces ultrasound in the diagnostic mix for breast cancer screening. It also opens doors for novel emerging modalities in cancer diagnostics. Many members of WMIS and participants of WMIS’s flagship event WMIC are involved in the development of novel technologies. Several members of WMIS and presenters at WMIC have developed solutions for pre-clinical and are now conducting research to understand the clinical applications.

WMIS takes a modality neutral view of the world. For WMIS members the recommendation for the approval of ultrasound test implies a step forward for the acceptance of new and emerging modalities. “For women, this is great news. It is also a powerful and motivating development for the researchers and members of WMIS who are developing novel solutions for patients,” said Kim Pierce, Executive Director of WMIS and a breast cancer survivor.

WMIS (World Molecular Imaging Society) is the world's most innovative and leading society in molecular imaging and molecular medicine. With the rise of the molecular imaging industry and the associated research, WMIS is the only organization that is connecting all the dots in the industry and is working to bring all stakeholders together by Smashing the Silos and Leading Innovation Convergence in molecular medicine; both for practitioners and researchers, who are defining the future of molecular imaging, WMIS enhances the potential and applications of innovation.

WMIC is the world's most innovative, science and technology led, event. It brings the world's top molecular imaging scientists, technology experts, researchers, and business leaders together to define the future of the molecular imaging field. As the most exciting event in the field, it attracts participation from across the entire value chain of molecular imaging.

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Al Naqvi
WMIS
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