Enable Injections Announces enFuse System Regulatory Approval & MRHA Medical Device Registration
Enable Injections, Inc. recently announced the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ANVISA) approved the enFuse system for administration of medication subcutaneously.
Approval of enFuse technology by ANVISA demonstrates that the enFuse on-body injector and enFuse syringe and vial transfer systems adhere to applicable Brazilian safety and quality standards and requirements, allowing distribution throughout the country.
The approval in Brazil marks a milestone in Enable’s partnership with Sobi, announced in September 2024, with plans to develop and distribute the enFuse system for the administration of Empaveli/Aspaveli in Sobi territories.
“Obtaining approval for the enFuse system in Brazil is an important regulatory milestone that underscores our commitment to bring our innovative technology to as many patients as possible, globally, who could benefit from a more comfortable administration experience,” said Michael D. Hooven, Chairman and CEO of Enable Injections. “By continuing to collaborate closely with our pharmaceutical partners, we remain steadfast in our mission to improve the lives of patients and caregivers through our wearable enFuse technology, minimizing disruption to their daily lives.”
In addition, the enFuse technology is registered in the UK with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (UK MHRA) as of June 6, 2025 and received European Union Medical Device Regulation (EU MDR) CE Mark in March 2025.
The enFuse on-body injector features hands-free, hidden needle drug delivery through a simple injection under the skin instead of intravenously, which is time-consuming and resource intensive. The enFuse system is designed to enhance the patient treatment experience by streamlining and improving at-home self-administration or in-clinic subcutaneous delivery of large volumes of pharmaceutical and biologic therapeutics.
Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse on-body drug delivery system. An innovative wearable technology, the enFuse system is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics.
Enable is currently working with a number of pharmaceutical partners to conduct clinical trials and plan for joint commercial launch of their therapies in combination with the enFuse technology. Enable’s enFuse technology received its first combination product US FDA approval in 2023. For more information, visit www.enableinjections.com.
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