FDA clears automated insulin delivery system from Sequel Med Tech

The twiist automated insulin delivery system. [Image courtesy of Sequel]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 the system, which is cleared for people ages six and up with type 1 diabetes.

Sequel CEO and co-founder Dr. Alan Lotvin said clearance marks “a pivotal first step” on the company’s mission. The company expects to distribute the system through the pharmacy channel as well. That should offer a convenient, affordable way to start on an AID system, Lotvin said.

Get the full story at our sister site, Drug Delivery Business News.

Read more
  • 0

United Therapeutics launches Remunity pump for Remodulin

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 specialty pharmacies in an effort to increase convenience for patients, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.

Read more
  • 0