EMED's New AccuSert® Needle Inserter Obtains FDA Clearance
EMED Technologies today announced that its AccuSert® needle insertion device obtained FDA clearance in Q4 2022 through a 510(k) Premarket Notification (K213429).
The AccuSert® is a reusable, mechanical, spring-loaded needle inserter that facilitates the insertion of needle sets for subcutaneous infusion of immunoglobulin, other biologics, and additional subcutaneous drugs. Indicated for single patient, multi-use, the device is placed in contact with the intended insertion site and activated to release the infusion set at a consistent 90° angle, supporting accurate placement and a comfortable patient experience.
"Our AccuSert® reusable device is an environmentally friendly clinical asset to patients. Distributors are increasing our footprint globally, and the AccuSert® reflects our commitment to delivering simple, reliable tools that make a real difference in everyday infusion therapy."
Paul LambertChief Executive Officer, EMED Technologies
The clearance further strengthens EMED's portfolio of subcutaneous infusion solutions and underscores the Company's commitment to advancing patient safety and clinical excellence.
For more information about AccuSert® and EMED's full portfolio, visit emedtc.com.
About EMED
EMED Technologies is an industry leader in the design, manufacture, and distribution of cutting-edge medical devices. For two decades, EMED Technologies has worked with clinicians, inventors, and medical companies to develop innovative medical products. Today, we are proud that both patients and clinicians can benefit from the fruits of our labor because we offer a wide variety of products and services that improve therapies and enhance clinical benefits. With our dynamic team of professionals, EMED continues to work with clinicians to understand their requirements and improve upon available technologies. In addition to novel technology, EMED is proud to offer licensing agreements for patented and proprietary technologies.
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