FDA Authorizes AI Platform for Breast Cancer Prediction
The FDA grants De Novo authorization for a new device for future five-year breast cancer risk prediction, based on an image alone.
Tag: breast cancer
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FDA Clears Lunit Insight DBT
Korean company Lunit has nabbed U.S. FDA clearance for its 3D Breast Tomosynthesis AI solution, Lunit Insight DBT, enabling its entry into the U.S. breast screening market.
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Aethlon Medical Earns NCI Grant to Research Breakthrough Device for Blood Purification
The Aethlon hemopurifier has been designated a "breakthrough device" by the U.S. FDA related to the treatment of life-threatening viruses not addressed with approved therapies. The proposed research entails an ex vivo evaluation of the medical device as a strategy for the capture and removal of exosomes from the plasma of patients with breast cancer.
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FDA Authorizes AI Platform for Breast Cancer Prediction
The FDA grants De Novo authorization for a new device for future five-year breast cancer risk prediction, based on an image alone.