Kubtec® announces FDA approval of world’s first breast specimen tomosynthesis system

MILFORD, CT (October 7, 2014) – Kubtec, the foremost developer of digital specimen radiography systems, marks the start of Breast Cancer Awareness Month with the announcement of U.S. FDA approval of MOZART® with TomoSpec®, the first and only breast specimen radiography system with tomosynthesis technology. In providing the most comprehensive analysis of excised breast tissue in a specimen radiography system, MOZART can help reduce re-excision and patient call back rates.  The speed and method with which the high resolution image slices are acquired mean shorter surgeries and less anesthesia time for the patient, lowering the risk of infection in hospitals.

“MOZART with TomoSpec allows 3D margin assessment in one step, without turning and repositioning the specimen container,” said Vikram Butani, President of Kubtec.  “The system captures an entire data set in less time than it takes to acquire multiple 2D images.  This is critical for delivering a higher level of care to women undergoing surgery for breast cancer.”

MOZART with TomoSpec is a mobile system that can be located in Radiology, Pathology or Surgery; images can be viewed in seconds with wireless transmission to PACS or directly on the system’s monitor.

“MOZART with TomoSpec provides a quantum leap forward in intraoperative specimen radiography, elevating the standard of care,” said Dr. Chester Lowe, Ph.D., FACR, Director of Research and Development at Kubtec. “Employing an elegant synthesis of digital technologies, MOZART with TomoSpec provides the most advanced specimen imaging available for breast tissue margin confirmation.”

MOZART with TomoSpec offers risk reduction, enhanced throughput, superior imaging capability, increased efficiency and ease of use for surgeons, radiologists, pathologists and health care facilities.

MOZART with TomoSpec is available worldwide.

View MOZART’s composite K-View image and 3D tomosynthesis video clip at www.kubtec.com/mozart.

About Kubtec
Kubtec, a registered trademark of KUB Technologies, Inc., develops and manufactures digital X-ray systems for specimen radiography, low-dose neonatal imaging, scientific research, forensic analysis, non-destructive testing, irradiation and more. With nearly 10 years of industry firsts, Kubtec is reigniting the field of radiography with its introduction of the world’s first specimen tomosynthesis system. Kubtec is ISO 9001 and ISO 13485 certified and complies and with U.S., Canadian, and European requirements for radiation safety.  Systems and manufacturer-trained support are available worldwide. http://kubtec.com