FDA clearance granted to QT Ultrasound® for new breast imaging device Transmission ultrasound technology provides 360° images and a new level of clarity for breast scans, without breast compression
Novato, CA – June 14, 2017 – QT Ultrasound LLC has received 510(k) marketing clearance from the U.S. Food and Drug Administration to market its Transmission Wave Ultrasound breast scanner. The company’s Transmission Ultrasound technology generates high fidelity 360° images of the breast with excellent image clarity. The elimination of radiation and breast compression make the QT scan™ an important additional breast imaging tool for physicians and the women they treat; at this time it is not intended as a replacement for screening mammography.
John Klock, M.D., founder and CEO of QT Ultrasound explains that the company’s recent publications have shown that Transmission Ultrasound technology is especially useful in seeing breast anatomy.
The company has initiated a broad-ranging clinical trial program designed to evaluate whether Transmission Ultrasound technology can (1) aid in the reduction of call-back and false-positive biopsy rates; and (2) replace screening mammography. “Our clinical trials are progressing to help us answer these important questions and learn how this new technology can make a difference in women’s health,” added Dr. Klock.
About QT Ultrasound
QT Ultrasound is a privately held company engaged in the research, development, and commercialization of transmission ultrasound technology. Their research has been supported by over $16 million in funding from the Cancer Imaging Program of the National Cancer Institute of the US National Institutes of Health. The company’s clinical trials have been conducted at many prestigious institutions in the US and Europe and it is currently enrolling women in trials at the Marin Breast Health Trial Center in Novato, California.