March 25, 2025 - 16:22
CINCINNATI, March 25, 2025 – Enable Injections, Inc. has achieved a significant regulatory milestone by receiving CE Mark approval for its enFuse® Syringe Transfer System under the European Union Medical Device Regulation (EU MDR). This approval paves the way for the company to introduce its groundbreaking wearable drug delivery platform across European markets.
The enFuse technology is designed to enhance patient experience by allowing for more efficient and comfortable drug administration. With the CE Mark in hand, Enable is now positioned to expand its reach and provide healthcare providers and patients in Europe with innovative solutions that prioritize convenience and efficacy.
The approval represents a crucial step in Enable's commitment to advancing healthcare technology and improving patient outcomes. The company’s leadership expressed enthusiasm about this achievement, noting that it validates their efforts in developing novel medical devices that meet rigorous regulatory standards. This marks a new chapter for Enable as it aims to transform the landscape of drug delivery in Europe.
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