Claims

QTbreasthealth and QT Ultrasound Claims References

*QTscan is FDA-cleared 

The QT Ultrasound Breast Scanner 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.

The QTscan should not be used by or for the following:

  • Those advised by their physician to avoid immersing their breast in water
  • Those with open wounds, sores or any condition which causes visible skin scaling and shedding on the breasts
  • Pregnant or lactating women
  • Those experiencing ANY nipple discharge
  • Patients weighing more than 400 lbs.
  • Those with a breast cup size greater than DDD or whose breast does not fit comfortably through the opening in the QTscanner table insert rings
  • Patients with magnetic implants, such as pacemakers, temporary breast implants or tissue expanders with magnetic ports, pain pumps or stimulators, or other devices or implants with magnetic properties
  • Those with allergies to chlorine, alcohol wipes, or medical grade adhesive tape.

1 More accurate than a mammogram and handheld ultrasound at identifying breast structures

QT breast scanning is highly accurate when compared to handheld. John C. Klock, Elaine Iuanow, Bilal Malik, Nancy A. Obuchowski, James Wiskin, and Mark Lenox. Anatomy-Correlated Breast Imaging and Visual Grading Analysis Using Quantitative Transmission Ultrasound. International Journal of Biomedical Imaging Volume 2016, Article ID 7570406, 9 pages http://dx.doi.org/10.1155/2016/7570406

John C Klock, Elaine Iuanow, Kathleen Smith, Nancy A and Obuchowski Visual Grading Assessment of Quantitative Transmission Ultrasound Compared to Digital X-ray Mammography and Hand-held Ultrasound in Identifying Ten Breast Anatomical Structures. BAOJ Clinical Trials 3: 015. (2017). https://bioaccent.org/clinical-trials/clinical-trials15.pdf

2 Comparable resolution to typical MRI

Mark W. Lenox, James Wiskin, Matthew A. Lewis, Stephen Darrouzet, David Borup, and Scott Hsieh, “Imaging Performance of Quantitative Transmission Ultrasound,” International Journal of Biomedical Imaging, vol. 2015, Article ID 454028, 8 pages, 2015. https://doi.org/10.1155/2015/454028.

Li X1, Huang W, Rooney WD. Signal-to-noise ratio, contrast-to-noise ratio and pharmacokinetic modeling considerations in dynamic contrast-enhanced magnetic resonance imaging. Magn Reson Imaging. 2012 Nov;30(9):1313-22. doi: 10.1016/j.mri.2012.05.005. Epub 2012 Jul 15. https://www.ncbi.nlm.nih.gov/pubmed/22795931

3 Half of women have dense breasts

https://ww5.komen.org/Breastcancer/Highbreastdensityonmammogram.html

4 Over 250,000 women in the US will be diagnosed with breast cancer this year

https://www.cancer.net/cancer-types/breast-cancer/statistics/2015

5 What it means to have dense breasts

https://www.mayoclinic.org/tests-procedures/mammogram/in-depth/dense-breast-tissue/art-20123968

6 Can exercise cause dense breasts?

https://www.breastcancer.org/risk/factors/dense_breasts

7 65.3% Percent of women aged 40 and over who had a mammogram in the past 2 years

CDC.gov. Health United States Report 2016 https://www.cdc.gov/nchs/data/hus/hus16.pdf#070

8 The only true 3D ultrasound technology

J.W. Wiskin, D. T. Borup, E. Iuanow, J. Klock and M. W. Lenox, "3-D Nonlinear Acoustic Inverse Scattering: Algorithm and Quantitative Results," in IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, vol. 64, no. 8, pp. 1161-1174, Aug. 2017. doi: 10.1109/TUFFC.2017.2706189

9 22% percent of breast cancer inaccurately diagnosed through mammography.

UC Health Today. How Accurate are Mammograms. https://www.uchealth.org/today/2015/07/06/how-accurate-are-mammograms/

10 Emerging new trend in ultrasound technology

Klock JC, Lenox MW, Wiskin JW, Malik B, Natesan R. Transmission Ultrasound Using 3D Inverse Scattering. Open Access E Book on Emerging Trends in Ultrasound. June 2018 http://openaccessebooks.com/emerging-trends-ultrasound-imaging/transmission-ultrasound-imaging-using-3D-inverse-scattering.pdf; ISBN: 978-93-87500-37-2.

11 19 to 1

Society of Breast Imaging

12 95% of false positives

PubMed Predicting the cumulative risk of false-positive mammograms. J Natl Cancer Inst. 2000 Oct 18;92(20):1657-66.

13 Quantitative Transmission Technology

J.W. Wiskin, D. T. Borup, E. Iuanow, J. Klock and M. W. Lenox, "3-D Nonlinear Acoustic Inverse Scattering: Algorithm and Quantitative Results," in IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, vol. 64, no. 8, pp. 1161-1174, Aug. 2017. doi: 10.1109/TUFFC.2017.2706189 https://www.hindawi.com/journals/ijbi/2015/454028/