World’s First Breast Specimen Tomosynthesis System Receives FDA Approval

In providing a comprehensive analysis of excised breast tissue in a specimen radiography system, a new breast specimen tomosynthesis system can help decrease re-excision and patient call back rates. The speed and technology with which the high resolution image slices are captured results in shorter surgeries and less anesthesia time for the patient, lowering the risk of infection in hospitals.

Kubtec (Milford, CR, USA), a developer of digital specimen radiography systems, recently reported on the US Food and Drug Administration (FDA) approval of Mozart with TomoSpec, the first and only breast specimen radiography system with tomosynthesis technology.


“Mozart with TomoSpec allows 3D [three-dimensional] 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 picture archiving and communication system (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, PhD, 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, excellent imaging capability, increased efficiency and ease of use for surgeons, radiologists, pathologists, and healthcare facilities.

The technology is available worldwide.

Kubtec develops and manufactures digital X-ray systems for specimen radiography, low-dose neonatal imaging, scientific research, forensic analysis, non-destructive testing, and irradiation. Kubtec introduced the world’s first specimen tomosynthesis system.

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Kubtec Mozart video