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Medical Devices / Submissions and Approvals

FDA Clears Subcutaneous Remodulin Delivery System

May 8, 2019
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The FDA granted United Therapeutics and DEKA 510(k) clearance for the RemUnity subcutaneous delivery system for Remodulin (treprostinil), a continuous pump therapy used to treat pulmonary arterial hypertension..

The lightweight pump controls the drug’s flow rates without the use of a motor using acoustic volume sensing technology and a solid-state actuator. The pump has a service life of at least three years.

United Therapeutics and DEKA are also developing a version of the device that uses prefilled disposable cartridges.

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