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allbiomedical > Product News Content > FDA PANEL RECOMMENDS APPROVAL FOR U-SYSTEMS’ BREAST CANCER
  
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FDA PANEL RECOMMENDS APPROVAL FOR U-SYSTEMS’ BREAST CANCER

FDA, U-SYSTEMS’ BREAST CANCER, Ultrasound (ABUS) system

U-Systems, the leader in automated breast ultrasound, announced that the U.S. Food and Drug Administration’s (FDA) Radiological Devices Panel of the Medical Devices Advisory Committee recommended approval of the somo•v® Automated Breast Ultrasound (ABUS) system.  U-Systems’ premarket approval (PMA) application is seeking a breast cancer screening indication for the somo•v ABUS system, which is currently FDA-cleared for diagnostic use as an adjunct to mammography. 

The somo•v® Platinum Automated Breast Ultrasound (ABUS) system was developed specifically to assist radiologists in the earlier detection of breast cancer. The result of 10 years of research and development, the somo•v ABUS system is designed to automatically scan a woman's breast capturing multiple ultrasound images and displaying them in 3D for review by a physician. ABUS is ideal for patients with dense breast tissue, where the effectiveness of mammography may be limited.
 
 

somo•v ABUS Exam

The somo•v Platinum delivers hardware and software performance updates to the somo•v Automated Breast Ultrasound (ABUS) system, the first ultrasound system designed specifically for the high-volume breast center environment.

The somo•v Platinum features U-Systems’ Reverse CurveTM Soft Touch transducer technology, a revolutionary new class of transducer designed to deliver unparalleled imaging performance and patient comfort.

Reverse Curve Soft Touch Transducer

The ergonomic Reverse CurveTM transducer conforms to the anatomic curve of a woman’s breast for improved comfort and imaging performance during an automated 3D ultrasound exam.  The Reverse Curve transducer uses convergent scan line geometry, enabling ultrasound beams, or sound waves, to penetrate the skin perpendicularly, improving penetration and sharpening focus at depth.  Additionally, the Reverse Curve creates uniform compression thickness across the entire breast enhancing image quality.  Overlapping wide field-of-view imaging ensures coverage of the complete breast.

somo•v Platinum Automated Breast Ultrasound

The somo•v Platinum with Reverse Curve, 14-6 MHz high frequency ultra-broadband transducer, delivers an industry leading 3D volume view of 15cm x 17cm x 5.0cm. The high center-frequency 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 Soft Touch 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.

Abella Workflow

Abella Workflow

Abella™ Workflow is a proprietary clinical workflow method for the quick, accurate review of automated breast ultrasound exams. Developed with input from over 16,000 somo•v ABUS studies, Abella Workflow is designed specifically for the high-throughput breast ultrasound screening environment.  Abella Workflow presents optimized ABUS 3D breast image volumes quickly, and in precise hanging protocols aimed at improving exam efficiency and clinical confidence.

Abella Workflow applies advanced image processing algorithms which reduce background noise, improve contrast and sharpen detail resolution. Combined with the imaging performance from the new Reverse Curve transducer, Abella Workflow delivers the industry’s most advanced approach to reviewing Automated Breast Ultrasound exams.

The Benefit: Initial clinical experience with Abella workflow demonstrates that trained clinicians can consistently and accurately review ABUS exams in three minutes or less with a high degree of clinical confidence.

Coronal View Correlates Better with Breast Anatomy

Body imagers recognize the importance of the coronal plane for providing accurate correlation with anatomical structures. The somo•v Platinum ABUS with Abella Workflow uses a patented Coronal Plane image display and proprietary pattern recognition software, to create a reading environment which allows rapid and intuitive analysis of intricate breast anatomy and pathology.

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About this company:
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.  
Company Information:
Company Name: U-Systems, Inc.
Address: 447 Indio Way
City: Sunnyvale
State/Province: CA
ZIP: 94085
Country: U.S.A.
Phone Number: +1-866-364-6777
FAX: +1-408-245-1970
 
Note: The copyright and the ownship of the brand, product names, product numbers, and content mentioned belongs to their repective companies.
 
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