Navigation Links
FDA Grants QT Ultrasound® Breakthrough Device Designation
Date:10/31/2018

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.* 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.* 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.* 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 an innovative automated breast imaging system producing high-resolution transmission ultrasound images. The company has received FDA clearance for its QTscan™, and the National Institutes of Health (NIH) awarded over $15 million in funding to continue QT Ultrasound research. The company’s clinical trials have been conducted at prestigious institutions in the US and Europe and include ongoing trials at the Marin Breast Health Trial Center in Novato, California. QTscans are now available commercially through the breast imaging centers of QTbreasthealth™.

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.

For more information about QT Ultrasound, visit qtultrasound.com.
For more information about the commercially available QTscan, visit qtbreasthealth.com.
For more information about clinical trials, visit marinbreasthealth.com.

*Sources:
American Cancer Society, Rethink Breast Cancer, NCBI

Read the full story at https://www.prweb.com/releases/fda_grants_qt_ultrasound_breakthrough_device_designation/prweb15881917.htm.


'/>"/>
Source: PRWeb
Copyright©2018 Vocus, Inc.
All rights reserved


Related medicine technology :

1. Bayer Awards $2 Million in Grants to Advance Hemophilia Research and Patient Care
2. WellCare Announces $20,000 in Grants to Help Reduce Tobacco Use and Promote Smoke-Free Environments in Kentucky
3. Neurim Pharmaceuticals Grants Exeltis Marketing Rights for Paediatric Prolonged-Release Melatonin ("PedPRM") in Spain
4. FDA Grants Orphan Drug Designation to CSRAs DynPort Vaccine Company for Plague Vaccine
5. Allergan Continues Commitment to Future of Headache Medicine with Educational Grants for Young Neurologists and Research Scientists
6. Rigel Pharmaceuticals, Inc. Announces Inducement Grants under NASDAQ Listing Rule 5635(c)(4)
7. FDA Grants Orphan Drug Designation to Amplyx Pharmaceuticals for APX001 for Treatment of Multiple Invasive Fungal and Mold Infections
8. Neurim Pharmaceuticals Grants Aspen Australia Marketing Rights for Paediatric Prolonged-Release Melatonin ("PedPRM") in Australia and New Zealand
9. FDA Grants Orphan Drug Designation to Debiopharm International SAs IAP Inhibitor Debio 1143 in the Treatment of Ovarian Cancer
10. Superdisintegrants Market Worth 416.5 Million USD by 2021
11. FDA Grants Second Orphan Designation For VAL-083
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/12/2019)... ... ... Through their Sidewalk Angels Foundation (SWA), Marisol and Rob Thomas, have joined forces ... from Lyme and other tick-borne diseases. We are all at risk of Lyme disease, ... this partnership SWA and GLA look to raise awareness about the real and every ...
(Date:6/12/2019)... ... 2019 , ... In the United States, there are more than 300,000 breast ... breast reconstruction plays an important part of healing. , As rates ... also increasing. There are many options available today for patients who choose to ...
(Date:6/11/2019)... (PRWEB) , ... June 11, ... ... leader in delivering optimal cost, quality and clinical outcomes, today announced the ... intelligence application is now available to current and prospective customers. , ...
Breaking Medicine Technology:
(Date:6/13/2019)... ... 2019 , ... Kno2 ®, the company that provides ... the company’s CEO, has been confirmed by the membership body as a Director ... industry alliance created to support secure, identity-proofed electronic exchanges of personal health information ...
(Date:6/13/2019)... ... June 13, 2019 , ... The University of Pittsburgh School of Health ... Health Informatics (MSHI ) degree program to address the growing need for professionals who ... part of a larger effort for SHRS to bring more graduate degrees online. The ...
(Date:6/12/2019)... ... June 12, 2019 , ... ... relationships with caregivers and dementia patients to deteriorate. , Researchers from the ... a survey with professional caregivers who care for people who have dementia and ...
(Date:6/12/2019)... ... June 12, 2019 , ... In September of 2018, NVNA and Hospice (NVNA) ... remote patient monitoring. Following its full-scale launch in March, NVNA has expanded its program ... beginning of 2019, NVNA has achieved an average all-cause hospital readmissions rate of 7.3% ...
(Date:6/12/2019)... ... June 12, 2019 , ... Millions ... life, preventing them from participating in education or the workforce, and even from ... to recognize communication as a human right and address communication disability in ways ...
Breaking Medicine News(10 mins):