Enable Injections, Inc., a company that focuses on creating new healthcare solutions, has shared the news that its enFuse on-body drug delivery system has been approved by Brazil’s Health Regulatory Agency, ANVISA. This approval means the enFuse system meets Brazil’s safety and quality requirements, allowing Enable to sell the device across the country. This achievement marks an important step in the company’s partnership with Sobi, which began in September 2024, to develop and distribute the enFuse technology for delivering Empaveli and Aspaveli in Sobi’s markets.
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Michael D. Hooven, Chairman and CEO of Enable Injections, said, “Getting the enFuse system approved in Brazil is a significant regulatory achievement that shows our commitment to bringing our innovative technology to as many patients as possible around the world who could benefit from a more comfortable way to take their medication.” He also mentioned that their continued work with pharmaceutical partners highlights Enable’s goal of improving the lives of patients and caregivers by offering a wearable device that makes medication easier to take without disrupting daily activities.
In addition, the enFuse system was registered with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (UK MHRA) on June 6, 2025. The device also received the CE Mark under the European Union Medical Device Regulation (EU MDR) in March 2025.
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The enFuse on-body injector delivers medication under the skin using a hands-free device with a hidden needle, offering a simpler option compared to intravenous delivery, which often takes more time and resources.
This technology is designed to improve the patient experience by making both home self-administration and in-clinic delivery of larger amounts of pharmaceutical and biologic treatments easier.
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