Ultrasound-Based Breast Imaging Device Gets FDA Clearance for Fibroglandular Volume Metrics

The Food and Drug Administration (FDA) has granted 510(k) clearance to QT Imaging’s ultrasound-based device QTscan for fibroglandular volume calculations that can help clinicians assess the effectiveness of non-surgical breast cancer treatment.

In addition to aiding in the assessment of breast cancer risk, QT Imaging said the ability of QTscan to calculate the ratio of fibroglandular volume to total breast volume enables radiologists to gauge the progress of non-surgical therapies for patients undergoing treatment for breast cancer. One can also use the fibroglandular volume ratio to monitor the use of selective hormone receptor modulation treatment, according to the company.

QT Imaging emphasized that the QTscan is the first ultrasound-based modality to receive FDA clearance for the quantification of fibroglandular volume.

Elaine Iuanow, MD, a breast imaging specialist, said the calculation of fibroglandular volume with QTscan is an “exciting” advance for the imaging and treatment of breast care patients.

“The ability to determine a therapeutic clinical response using a quantitative volumetric method is crucial for effective and timely treatment of breast cancer and for patients at high risk for developing breast cancer who are receiving hormonal therapy,” noted Dr. Iuanow, a consultant for QT Imaging.

Offering a combination of transmission ultrasound and reflection ultrasound, the QTscan provides “highly accurate” 3D imaging of breast tissue, according to QT Imaging. The company maintained the lack of radiation or compression with the QTscan device allows for more frequent monitoring of adjuvant chemotherapy or radiation therapy in the treatment of breast cancer.

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