Quantitative Transmission Ultrasound Technology

What is QT?

QT stands for Quantitative Transmission Ultrasound, a technology that allows us to produce high-fidelity images at comparable resolution to a typical MRI.1 Without radiation, compression or injections.

What makes this emerging technology important is that images are generated using both reflection and transmission modalities. It has been shown that transmission ultrasound can be used to characterize findings in the busy breast.

The QTscan’s ‘transmission’ imaging is quantitative in nature, and provides us with critical information which is unique and distinct for each tissue type. This may allow doctors to better assess breast health.

See how Quantitative Transmission Ultrasound works

Mark Lenox, Ph.D., Chief Technology Officer of QT Ultrasound explains the QTscan difference.

In this real patient scan, the QT algorithm systematically characterizes and strips away normal tissues to expose the underlying suspicious mass.

Eliminating the dense breast challenge

3D mammography does not show mass in breastMammography
Mass discovered in Handheld Ultrasound scanHandheld Ultrasound
Breast MRI
QT Scan

Case study of a single subject with a suspicious mass as viewed across multiple imaging modalities. The mass was not detected in the mammogram modality. The handheld ultrasound showed a suspicious finding but could not confirm the type of mass. MRI and QTscan identified the mass.

QTscan was able to produce a high-definition 3D image with no radiation, no compression, and no injections and may have been able to detect the mass before it was even felt by the patient.

The QTscan could be the right option for you

Dense breasts?
Dense breasts

QTscan can image through dense breasts to provide reassurance, instead of false positives

Cindy holds an image of her QTscan breast imaging results after a mammogram
Breast implants

For women who need clearer imaging results

Frequent follow-up imaging

Get a second opinion without risk of radiation- at any age

Secondary imaging

When recommended based on the results of a mammogram

Contact

If you have more questions, talk with one of our specialists

We're on a mission to shift the paradigm of breast imaging

QT Ultrasound timeline of accomplishments in advancing the technology.

06.06.17
FDA 510(K) CLEARANCE K162372

Cleared for marketing in the U.S.

The QT Ultrasound Breast Scanner – 1 is for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.

09.24.18
FDA 510(K) CLEARANCE K182213

Cleared for advanced imaging methods for the QT Scanner in the U.S.

Approved Research Mode for the QTViewer™. Research mode includes doubling time and quantitative breast density (QBD®) for researchers.

10.30.18
BREAKTHROUGH DEVICE DESIGNATION*

If clinical trials accepted by the FDA it will be the first new modality cleared for screening since the mammogram > 50 years ago

The device is intended to be used as an initial evaluation method for asymptomatic women identified with above-average risk for developing breast cancer based upon genetic testing and/or other established criteria or women who have not reached the age of mammography screening for their risk level in applicable breast cancer screening guidelines.

*Requires successful completion of pre-market FDA application before it is cleared for marketing.

QT Ultrasound Leadership

Our leadership team of physicians and seasoned executives has decades of experience in medicine, health care delivery, technology and innovation. Though their backgrounds are diverse, each QT leader shares an unrelenting desire and commitment to evolve breast imaging for women everywhere.

Learn more about the team behind QT

Press Releases

FDA Grants QT Ultrasound® Breakthrough Device Designation

The FDA has designated the QT Ultrasound Breast Scanner as meeting an unmet medical need for screening women at high risk for breast cancer
Read the press release

Novato, CA –October 31, 2018 –

Today the Food and Drug Administration (FDA) granted  QT Ultrasound LLC’s Breakthrough Device designation request for its QT Scanner 2000 Model A.  Unlike traditional breast imaging modalities, the company’s QTscan™ has no radiation, no injections, and no compression, potentially offering new opportunities for earlier and more frequent screening for young women at high risk for breast cancer who have no available FDA-cleared screening options.

Women at high risk have a 20% lifetime risk of developing breast cancer.1 Causes include genetic factors, family history, and exposure to radiation. With one first-degree female relative, such as a mother or sister, diagnosed with breast cancer, a woman’s risk is doubled. Women who carry a mutation in their BRCA 1 or BRCA 2 genes have a 40-85% lifetime risk of developing breast cancer and are more likely to develop breast cancer at a younger age. 2 While only about 7% of women with breast cancer are diagnosed before the age of 40 years, the most aggressive form of breast cancer and the worst survival rates occur in younger women.3 However, routine mammograms are not recommended for women under 40 years old. Quantitative Transmission Ultrasound is an emerging trend in ultrasound technology that can see through dense breasts and uses no radiation, giving it the potential to have significant benefits for younger women at high risk. “Breast cancer screening is important for all women, but women who are at a higher risk of breast cancer may need to be screened earlier and more often than other women. We hope to provide an imaging option that is safe, comfortable, and effective.” Says Dr. John Klock, CEO and Founder of QT Ultrasound.

The proposed indications for use, as designated by the FDA as breakthrough are:

“The QT Ultrasound Breast Scanner is an ultrasonic imaging system that provides reflection-mode and transmission-mode images of a patient’s breast, without emitting ionizing radiation. The device is intended to be used as an initial evaluation method for asymptomatic women identified with above-average risk for developing breast cancer based upon genetic testing and/or other established criteria, who have not reached the age of mammography screening for their risk level in applicable breast cancer screening guidelines. Diagnostic work-up of findings may follow as clinically appropriate. The QT Scanner is not to be used as a replacement for standard screening mammography.”

The company will be working with the FDA to submit an appropriate pre-market submission.  If approved, the device may be legally marketed for use as a breast cancer screening device in younger women at high risk for breast cancer.

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.

FDA clearance granted to QT Ultrasound for new breast imaging device

Transmission ultrasound technology provides 360-degree images and a new level of clarity for breast scans, without breast compression.
Read the press release

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.

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.

Let's put the decision making about your breast health in the most qualified hands — yours.

Schedule your QTscan

To discuss the benefits of a QTscan or to schedule an appointment, call 833-478-7226, or provide your contact information through our secure form below and one of our care consultants will contact you.

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