Kubtec secures FDA approval for first breast specimen tomosynthesis system

7 October 2014 (Last Updated October 7th, 2014 18:30)

Kubtec has received approval from the US Food and Drug Administration (FDA) for its MOZART with TomoSpec, the first and only breast specimen radiography system with tomosynthesis technology.

Kubtec has received approval from the US Food and Drug Administration (FDA) for its MOZART with TomoSpec, the first and only breast specimen radiography system with tomosynthesis technology.

MOZART provides the most comprehensive analysis of excised breast tissue in a specimen radiography system, which helps in reducing re-excision and patient call back rates.

The system provides high-resolution images in less time and this method offers shorter surgeries and less anesthesia time for patients, reducing the risk of infection in hospitals.

Kubtec president Vikram Butani said: "MOZART with TomoSpec allows 3D margin assessment in one step, without turning and repositioning the specimen container.

"MOZART with TomoSpec allows 3D margin assessment in one step, without turning and repositioning the specimen container."

"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."

This mobile system that can be located in Radiology, Pathology or Surgery, while images can be viewed in seconds with wireless transmission to picture archiving and communication system (PACS) or directly on the system's monitor.

Kubtec Research and Development director Dr Chester Lowe said: "MOZART with TomoSpec provides a quantum leap forward in intraoperative specimen radiography, elevating the standard of care.

"Employing an elegant synthesis of digital technologies, MOZART with TomoSpec provides the most advanced specimen imaging available for breast tissue margin confirmation."

The new system provides risk reduction, improved throughput, better imaging capability, increased efficiency and ease of use for surgeons, radiologists, pathologists and health care facilities.