Exclusives
FacebookTwitterLinkedInGoogle+RSS Feed
Fire EMSEMS TodayEMS Insider

Medical Device Firm iTraumaCareTM Receives FDA 510(k) Clearance for iTClampTM Hemorrhage Control System

[May 28, 2013 – SAN ANTONIO, TEXAS]  iTraumaCare, an early-stage medical device firm focused on developing traumatic injury solutions for first responder and military medicine applications, has achieved its third regulatory milestone. The US Food and Drug Administration (FDA) granted the company 510(k) clearance to market its first product, the iTClampTM Hemorrhage Control System, in the United States. The product, which was licensed for sale in Canada in late 2012 and received its CE Mark for sale in Europe in March 2013, will be available to medical professionals in the US within 30 to 45 days. 

The iTClamp™ is designed to control severe bleeding – a leading cause of death in traumatic injury – in seconds.  The iTClamp™ seals the edges of a wound closed to create a temporary pool of blood under pressure, which forms a stable clot that mitigates further blood loss until the wound can be surgically repaired.

510(k) clearance by the US FDA indicates that the iTClamp™ meets with the FDA’s regulatory standards for patient safety and efficacy.  FDA clearance is required for the commercial sale and distribution of Class II medical devices in the US, like the iTClamp™. 

iTraumaCare’s CEO and founder, Dr. Dennis Filips, said, “With this regulatory milestone achieved, we look forward to putting the iTClamp in the hands of health care professionals in the United States and improving patient care.”

Incorporated in 2010 and based in Edmonton, Canada with its global commercialization headquarters in San Antonio, Texas, iTraumaCare is addressing unmet needs in the field of emergency medicine by developing, manufacturing, and commercializing solutions to treat common causes of preventable death in traumatic injury scenarios. 

RELATED ARTICLES

HGH EMS Rescue Says Burning Man 'Lessons' Will Be Invaluable Moving Forward

HGH EMS Rescue issues a statement after being notified that their four-year contract providing medical care at the annual counter-culture festival has been t...

Richmond Ambulance Authority Receives American Heart Association's Mission: Lifeline EMS Recognition Award

AHA honors Richmond Ambulance Authority for implementing quality improvement measures for the treatment of patients who experience severe heart attacks.

Onspot Announces the Addition of an Eastern Canada Regional Manager

Daniel replaces Pat Freyer who has covered this region for the past 26 years. Pat will continue on with Onspot as President and CEO.

EMS Compass Initiative Looks to Community for Input

EMS Compass brings together many of the nation’s leading minds in EMS, healthcare and performance improvement, including the expertise of the Institute for H...

FLIR Adds New Member to Family of FSX-enabled Firefighting Cameras

The K45 with FSX presents accurate thermal images on a bright, large 4” LCD display, allowing firefighters to navigate safely and make accurate decisions whe...

Drager Joins Forces with Code 3 for a Cure to Address Firefighter Cancer

The two organizations formally announced their alliance at FDIC International, the world’s largest firefighter training conference in the United States, held...

Features by Topic

JEMS Connect

CURRENT DISCUSSIONS

 
 

EMS BLOGS

Blogger Browser

Today's Featured Posts

Featured Careers