NEW

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...

Advanced Cooling Therapy Expands Team

Medical device firm Advanced Cooling Therapy (ACT) has expanded its team and achieved several strategic milestones in the commercial launch of its first product, the Esophageal Cooling Device (ECD).

Within less than 90 days of obtaining its de novo clearance from the FDA and manufacturing labeled product, the company has already had its first U.S. sales of the ECD, along with first human use in the country. A total of four clinical papers have now been published globally on the efficacy of the device.

To support the strong demand for the ECD, the company promoted Robin Drassler to Vice President of North American Sales, hired Maria Gray MA, RN, as Director for Clinical Services and added key sales managers to accommodate growth in the U.S. and globally.

The ECD is a temperature modulation device that is approved to use the esophageal environment for whole-body temperature modulation, including both cooling and warming. It’s designed to modulate and control patient temperature when clinically indicated through a single use, fully enclosed triple lumen system that is inserted into the esophagus. It received FDA de novo clearance in June of 2015, its CE Mark in Europe in 2014, and is licensed for sale in Canada and Australia. •

Previous

Next

Submit a Comment

Your email address will not be published. Required fields are marked *

X