FDA, Cardinal Health Assess Scope of Potential Contamination Risk

Dr. Jeffrey E. Shuren MD, JD, Director - CDRH Offices: Office of the Center Director, released the following statement on Thursday (January 16, 2020): “On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to...

U.S Health System Uses Medtronic Stealth Autoguide Cranial Robotic Guidance Platform

Phoenix Children’s Hospital is the first-ever health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth Autoguide platform.

Cook Medical TriForce Peripheral Crossing Set Now Available

Cook Medical’s TriForce® Peripheral Crossing Set is now commercially available. As of January 2020, these products are available to physicians in the United States to support procedures to treat patients with vascular obstructions.

PENTAX Medical Launches IMAGINA Endoscopy System in U.S.

IMAGINA offers practitioners a modern user interface and unique endoscope design to provide excellent visualization, improve the operator experience and positively influence long-term patient care costs.

New Study Demonstrates that use of Interoperative Specimen Tomosynthesis Reduces the Re-excision Rates for Breast Cancer Surgery by 50%

A new study presented at the 20th Annual Meeting of the American Society of Breast Surgeons in Dallas last week demonstrates how the KUBTEC Mozart Specimen Tomosynthesis System enables tangible improvements in care for breast cancer patients.

The study of over 500 patients, presented by a team from University of Texas South Western, in Dallas TX titled ‘Differences in Re-excision Rates for Breast Conserving Surgery Using Intraoperative 2D vs. 3D Tomosynthesis Specimen Radiograph’, concludes that the use of KUBTEC’s proprietary Specimen Tomosynthesis technology during breast cancer surgery reduces re-excision rates by more than 50% compared to the traditional 2D imaging methods commonly in use.

Currently in the US around 25% of patients having breast conserving surgery for cancer require a second surgery, or re-excision, because of failure to remove all the tumor during the first surgery. With over 180,000 surgeries being performed each year in the US, re-excisions are a major source of expense to the hospital, and cause additional discomfort, trauma and scarring for patients.

The authors conclude that Specimen Tomosynthesis is “independently associated with a lower re-excision rate (over 50% reduction)”, and that this “translates into decreased return to the operating room, decreased anxiety levels and costs to our patients.”

John Leach, Vice President of Marketing at KUBTEC, said “This important study is one of several that demonstrate the positive impact the Mozart System has on breast cancer treatment. This unique technology reduces treatment costs and offers improved clinical outcomes for patients. As a result, we are seeing high demand for the Mozart System as it continues to be adopted by breast cancer centers of excellence worldwide”.



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