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Deka Research and Development

FDA clears automated insulin delivery system from Sequel Med Tech

March 18, 2024 By Sean Whooley

sequel twiist automated insulin delivery AID system

Sequel Med Tech announced today that its partner, DEKA R&D, won FDA 510(k) clearance for its automated insulin delivery (AID) system. The twist system, powered by Tidepool, directly measures the volume and flow of insulin delivered with every microdose. It offers the capability and flexibility to address each patient’s individual dosing needs. Sequel will market […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Technology Tagged With: Deka Research and Development, Sequel Med Tech

United Therapeutics launches Remunity pump for Remodulin

February 10, 2021 By Sean Whooley

united-therapeutics-deka

United Therapeutics (NSDQ:UTHR) announced today that it launched its Remunity pump for Remodulin in patients with pulmonary arterial hypertension (PAH). Research Triangle Park, N.C.-based United Therapeutics’ Remunity pump initially received FDA clearance in May 2019 for patient filling, adding another 510(k) clearance in February 2020 to enable cassettes to be prefilled with Remodulin by contracted […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular Tagged With: Deka Research and Development, United Therapeutics

FDA clears RemUnity drug pump co-developed by Deka, United Therapeutics

May 7, 2019 By Danielle Kirsh

united-therapeutics-deka

United Therapeutics and Deka Research and Development have received FDA 510(k) clearance for the co-developed RemUnity system. The RemUnity system is a subcutaneous delivery system for Remodulin injections. The two companies have co-developed the device that is indicated to treat pulmonary arterial hypertension. “We developed the RemUnity system to address safety and patient convenience problems […]

Filed Under: Regulatory/Compliance Tagged With: Deka Research and Development, United Therapeutics

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