www.fdanews.com/articles/191212-fda-clears-subcutaneous-remodulin-delivery-system
![ClearanceStamp_Gray.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Gray.gif?t=1576043982&width=430)
FDA Clears Subcutaneous Remodulin Delivery System
May 7, 2019
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.