Launch of a new x-ray diffraction mammography system study by Calidar
Duke University-originated diagnostic imaging startup, Calidar, has initiated the first in-human study of its innovative x-ray diffraction 4D Mammography system. The study, announced on August 19, is being conducted in collaboration with Baptist Health Hardin in Elizabethtown, KY.
The 4D Mammography system uses x-ray diffraction technology to measure how x-rays scatter at the molecular level, producing a unique structural signature that reflects the internal composition of breast tissue. This signature allows for a more precise classification of cancerous and benign samples, with studies showing a four-fold improvement in accuracy compared to conventional imaging techniques.
The study will evaluate the system's ability to distinguish between healthy tissue and breast cancer in patients. It will also compare the performance of Calidar's 4D Mammography system with existing mammogram systems.
It's important to note that the 4D Mammography system is investigational and has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The system is limited to investigational use in the U.S. under the FDA's abbreviated Investigational Device Exemption (IDE) requirements.
Calidar's focus for the current study is on the diagnostic use of the 4D Mammography system, with patients who have findings requiring evaluation. Future studies are planned to investigate the system's use in breast cancer screening.
Unfortunately, the search results do not provide specific information about the doctors involved in the clinical study.
This first-of-its-kind study marks a significant step forward in the field of breast cancer diagnosis, potentially paving the way for more accurate and efficient detection methods. As the study progresses, we can expect to gain a better understanding of the potential benefits and applications of Calidar's 4D Mammography system.
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