QT Imaging has received US Food and Drug Administration (FDA) 510(K) clearance to measure the fibroglandular volume (FGV) of the breast and the ratio of FGV to total breast volume (TGV) on its QTscan breast imaging system.

According to the company, the FGV ratio can help determine the risk for breast cancer, and changes in it can be used to calculate the efficacy of medication used in the treatment or prevention of the cancer.

QT Imaging CEO, chief medical officer and founder John Klock said: “We are excited to expand the tools available using low frequency transmitted ultrasound volography to serve women, especially those with dense breasts, providing an imaging option that is safe, comfortable, and effective.”

As per the FDA indications, the QT Scanner 2000 Model A is intended for use as an ultrasonic imaging device to deliver pictures of a patient’s breast in both reflection and transmission modes.

The software of QT Scanner 2000 Model A can also calculate the breast FGV value and the ratio of FGV to TBV value as indicated from the reflection-mode and transmission-mode ultrasound images of a patient’s breast.

The tool is not indicated to be used as a replacement for screening mammography.

QTscan allows for earlier and more frequent monitoring of women receiving non-surgical breast cancer treatments like adjuvant chemotherapy, cryotherapy, radiation therapy, and hormone or selective hormone receptor modulation treatments, said QT Imaging.

Unlike conventional breast imaging modalities, it does not need radiation, compression, or injection, and is highly accurate, claimed the company.

QT Imaging breast imaging specialist and medical consultant Elaine Iuanow said: “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.

“The FGV tool will allow this assessment to be made early and in follow-up to maximize treatment benefit, which is an exciting development for breast care patients.”