Enable Injections Announces Regulatory CE Mark Approval in Europe for enFuse Technology
CINCINNATI, March 25, 2025 (GLOBE NEWSWIRE) -- Enable Injections, Inc. (“Enable”), a healthcare innovation company developing and manufacturing the enFuse® wearable drug delivery platform, today announced it has received its European Union Medical Device Regulation (EU MDR) CE Mark approval of the enFuse Syringe Transfer System. This approval allows Enable to deliver its innovative solutions throughout the EU.
“The CE Mark is a significant milestone in our regulatory journey, validating our novel technology and demonstrating our commitment to the highest standards of quality and safety for patients,” said Michael D. Hooven, Enable Injections' Chairman and CEO. “This approval increases credibility and confidence in our product by regulatory authorities, empowering Enable to reach patients internationally. We look forward to working with our current and future partners to commercialize our platform throughout the European Union.”
The enFuse on-body delivery system is intended for subcutaneous abdominal bolus administration of drug or biologic products in accordance with the drug product requirements.
Designed to streamline and improve in-clinic or patient self-administration, the wearable enFuse technology features hands-free, hidden needle drug delivery through a simple injection under the skin, instead of intravenously.
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. The first enFuse combination product received U.S. FDA approval in 2023.
About Enable Injections
Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of enFuse. enFuse is an innovative wearable drug delivery platform that 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. For more information about the Company’s approved enFuse combination production, visit https://enableinjections.com/our-products.
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