somo•v™ Automated Breast Ultrasound System (ABUS)

Introducing somo•v™ INSIGHT Class
Automated Breast Ultrasound System (ABUS)

Establishing the Standard for Breast Ultrasound Screening

U-Systems developed the somo•v™ INSIGHT Class technology as the foundation for a ground-breaking, prospective clinical study evaluating the sensitivity of digital mammography in combination with the somo•v ABUS system in women with dense breasts.

Learn more about this ground-breaking study at SOMOINSIGHTStudy.org

somo•v INSIGHT Class Performance Delivers Precise Anatomical Detail

The somo•v INSIGHT Class LHD14-6 high frequency 14 MHz automated ultra broadband transducer delivers an industry leading 3D volume view of 15cm x 17cm x 5.0cm. The high center-frequency significantly sharpens detail resolution while the ultra broadband performance simultaneously delivers distinct contrast differentiation, resulting in precise anatomical detail of complex breast tissues and structures.

The Benefit: Superior image quality provides greater diagnostic confidence.

Consistent and Reproducible Breast Exams

U-Systems patented breast stabilization membrane and proprietary positioning protocols enable rapid and reproducible breast exams, saving time and improving consistency.

The Benefit: Reproducible breast ultrasound examinations allow accurate comparison of images obtained from a previous study.

Coronal View Correlates Better with Breast Anatomy

Body imagers recognize the importance of the coronal view or C-plane for providing accurate correlation with anatomical structures.

The somo•v INSIGHT Class workstation combines patented C-plane Thick-Slice Imaging with proprietary Pattern Recognition software, creating an environment which allows rapid and intuitive analysis of intricate breast anatomy and pathology.

The Benefit: C-Plane image detail correlates with breast anatomy allowing intuitive analysis and rapid detection of pathology.

U-Systems Receives Approval for Ultrasound Breast Cancer Screening

First-Ever Approval for Ultrasound Breast Cancer Screening Indication Granted to U-Systems’ somo•v™ Automated Breast Ultrasound (ABUS) System

SUNNYVALE, Calif.–(BUSINESS WIRE)–U-Systems, the leader in automated breast ultrasound, today announced that it has received approval to market the somo•v™ Automated Breast Ultrasound (ABUS) system as an adjunct to mammography for screening asymptomatic women for breast cancer in the European Union.

“This represents a major advancement in breast health for women as study after study, have demonstrated a need for additional tools to improve the early detection of breast cancer, particularly in women with dense breast tissue which impacts detection and carries an increased risk of breast cancer.”

Approval was based on extensive clinical evidence and includes the following indication: “The intended use of the somo•v ABUS system is to provide a significant increase in breast cancer detection and sensitivity of Interpreting Physicians in diagnosing symptomatic and screening asymptomatic women as an adjunct to mammography.”

“We are excited that the somo•v ABUS now has CE mark approval for breast cancer screening. The somo•v ABUS is the first and only approved automated ultrasound system for screening asymptomatic women,” said Ron Ho, president and CEO of U-Systems. “This represents a major advancement in breast health for women as study after study, have demonstrated a need for additional tools to improve the early detection of breast cancer, particularly in women with dense breast tissue which impacts detection and carries an increased risk of breast cancer.”

“The somo•v ABUS is not intended as a replacement for mammography, which remains the most effective screening tool for many women. However, we have strong scientific evidence that for women with dense breast tissue, supplementing mammograms with somo•v ABUS can substantially increase breast cancer detection,” added Ho.

“The sensitivity of screening mammography is limited in women with dense breasts, as low as 30-50%,” said László Tabár, M.D., F.A.C.R. (Hon) Professor of Radiology, Uppsala University School of Medicine, and Medical Director at the Department of Mammography Falun Central Hospital, Falun, Sweden. “It is essential to have a multimodality screening approach for detecting breast cancer at an early stage, to prevent women from dying from this disease. The somo•v Automated Breast Ultrasound system fulfills this important need in the multimodality approach.”

U-Systems is currently sponsoring the SOMO·INSIGHT Clinical Study, the largest clinical research study ever undertaken by an ultrasound company. The study is designed to evaluate whether digital mammography in combination with the somo•v Automated Breast Ultrasound system is more sensitive than a routine screening mammogram alone in detecting breast cancer in women with greater than fifty percent dense breast tissue. To date, more than 9,000 women have participated in the study which is actively recruiting up to 20,000 women at multiple breast imaging centers in the United States. The SOMO·INSIGHT Clinical Study has identified a significant number of mammographically negative breast cancers that would not have been detected had the participants not had an ABUS exam. Learn more about the SOMO·INSIGHT Study at: http://www.somoinsightstudy.org.

About U-Systems

As the leader in automated breast ultrasound technology U-Systems is establishing the standard for breast ultrasound screening. The U-Systems’ somo•v Automated Breast Ultrasound (ABUS) system and somo•viewer Advanced 3D Workstation are cleared under 510(k) for diagnostic use as an adjunct to mammography. For more information about U-Systems, please visit our website at http://www.u-systems.com.

For more information about this ground breaking technology please contact U-Systems at inquiries@u-systems.com or by calling 1-866-364-6777 begin_of_the_skype_highlighting              1-866-364-6777      end_of_the_skype_highlighting

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