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 iTClamp^TM 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 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.
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