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FDA clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing

The U.S. Food and Drug Administration today cleared for marketing in the U.S. the first fully disposable duodenoscope. The EXALT Model D Single-Use Duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct...

Webinar Addresses ‘Hot Topic’

The recent OR Today webinar “Human Factors and Quality Testing for Device Reprocessing” was sponsored by Healthmark and eligible for one (1) continuing education (CE) hour by the State of California Board of Registered Nursing. The 60-minute webinar featured Jahan...

Nihon Kohden Introduces First Subscription-Based Pricing for Patient Monitoring, Neurology Products

Nihon Kohden, a U.S. market leader in precision medical products and services, has launched subscription-based pricing models for its patient monitoring and neurology products, the first in the industry to take such a step. The pricing models help align costs with...

Nihon Kohden Launches Life Scope SVM-7200 Series

Nihon Kohden has announced the launch of its Life Scope SVM-7200 Series vital signs monitor, a monitor designed for outpatient facilities and beds that traditionally are not continuously monitored. The monitor allows health care practitioners to quickly and easily...

neoSurgical Begins Postmarket Surveillance Study

neoSurgical Inc. has begun a postmarket surveillance study of its FDA-cleared device, neoClose, at University of Texas Health Sciences Center at Houston. The randomized study will compare neoClose against the standard of care for closure in a bariatric surgery gastric bypass population of 70 adults aged 18-70 years with BMI greater than 35.
Principal investigators include: Erik B. Wilson, M.D., professor of surgery; Peter A. Walker, M.D., assistant professor of surgery; and, Shinil K. Shah, DO, assistant professor of surgery.

“Surgeons in hospitals across the United States are rapidly adopting our neoClose device. This postmarket surveillance study is intended to build our clinical evidence behind neoClose and to begin to establish the superiority of neoClose versus the standard of care for closing port sites – a standard that absolutely must be improved to enhance patient outcomes and safety,” said Barry Russell, CEO of neoSurgical. •

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