QT Imaging Receives 510(k) Clearance for QTscan

QT Imaging has received 510(k) clearance from the FDA for its QTscan 3D ultrasound breast imaging device.

The device is cleared for use in calculating the fibroglandular volume (FGV) of the breast and the ratio of FGV to total breast volume. The calculation can help assess the risk for breast cancer and changes in the ratio can be used to measure the efficacy of medication used to treat or prevent breast cancer.

The ultrasound device does not require radiation, injection or compression of the breast and it allows for earlier and more frequent monitoring of women undergoing nonsurgical breast cancer treatments such as chemotherapy, radiation therapy, cryotherapy and hormone or selective hormone receptor modulation treatments.

The device is not intended to be used as a replacement for mammography screenings.