FDA clears gel-e Flex for OTC use
Gel-e announced on Friday that the U.S. Food and Drug Administration has green lighted the company’s expansion of its OTC label with the approval of gel-e Flex for OTC use of its first flowable hemostat.
This new clearance expands the company's label that now includes the use of gels and bandages in the local management of bleeding, such as lacerations and minor bleeding. These products are specifically designed to create rapid hemostasis through easy-to-use applications for professional healthcare providers, parents, coaches, adult caregivers and even patients themselves. Gel-e Flex also complements the company's already FDA-cleared vascular closure device, Vascular gel-e, as it can be worn home by patients to manage any residual bleeding from an out-patient diagnostic or interventional procedure.
"This clearance is the next step in expanding our OTC product line, and will be a key component of gel-e's 21st Century First Aid Kit," said Matthew Dowling chief scientific officer at gel-e. "We are continuing to develop a tool kit that will provide the best possible options for all manner of chronic and acute wounds. The versatility of these flowable and bandage formats represents an important progression towards our next-generation kit and eventually to products that can be used in surgery."
This new clearance expands the company's label that now includes the use of gels and bandages in the local management of bleeding, such as lacerations and minor bleeding. These products are specifically designed to create rapid hemostasis through easy-to-use applications for professional healthcare providers, parents, coaches, adult caregivers and even patients themselves. Gel-e Flex also complements the company's already FDA-cleared vascular closure device, Vascular gel-e, as it can be worn home by patients to manage any residual bleeding from an out-patient diagnostic or interventional procedure.
"This clearance is the next step in expanding our OTC product line, and will be a key component of gel-e's 21st Century First Aid Kit," said Matthew Dowling chief scientific officer at gel-e. "We are continuing to develop a tool kit that will provide the best possible options for all manner of chronic and acute wounds. The versatility of these flowable and bandage formats represents an important progression towards our next-generation kit and eventually to products that can be used in surgery."