NEW

Getinge, Cook Medical Reach iCast Distribution Agreement

Getinge and Cook Medical have announced an exclusive sales and distribution agreement for the iCast covered stent system.

Endorail Earns FDA 510(k) clearance: Next-generation magnetic balloon technology optimizes colonoscopy procedural outcomes

Endostart, a pioneering medical device company specializing in gastrointestinal endoscopy solutions, HAS announces a major breakthrough with the FDA 510(k) clearance of its flagship product, Endorail. This achievement represents a significant step forward in advancing...

Survey: Nurse Shortage a Leading Threat to Industry

In honor of Certified Nurses Day, health tech company Carta Healthcare®, whose mission is to harness the value of clinical data, today released the results of a survey about the pain points that health care professionals are currently experiencing. The survey also...

Modular Lab Furniture Systems Meet Needs

UniLine Furniture offerings from HEMCO Corp. include base cabinets, wall cabinets, countertops, sinks, fixtures, base tables, mobile work stations, specialty storage cabinets and peg boards.

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Your email address will not be published.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