Search results for "FDA Update"
Recent FDA announcements deal with insulin pumps
The agency announced a recall of a series of Medtronic insulin pumps and offered information about preventing damage to pumps and monitors during CT scans and X-rays.
https://diabetes.acponline.org/archives/2024/11/08/9.htm
8 Nov 2024
FDA advisors vote against weekly insulin for type 1 diabetes
In other diabetes-related actions, the FDA recently authorized marketing of an app for automated insulin delivery and warned about software issues with an existing app and insulin pump.
https://diabetes.acponline.org/archives/2024/06/14/11.htm
14 Jun 2024
FDA warns about smartwatches, rings to measure glucose
Smartwatches and smart rings that claim to measure blood glucose levels without piercing the skin are being sold commercially, but none have been approved by the FDA, the agency warned.
https://diabetes.acponline.org/archives/2024/03/08/8.htm
8 Mar 2024
First over-the-counter CGM cleared for marketing
The integrated continuous glucose monitor (CGM) is intended for anyone ages 18 years and older who does not use insulin.
https://diabetes.acponline.org/archives/2024/03/08/7.htm
8 Mar 2024
CGM software authorized, infusion sets recalled, tirzepatide approved for obesity
The FDA cleared a software system that works with continuous glucose monitors (CGMs) and insulin pumps for marketing and announced the recall of some lots of insulin infusion sets.
https://diabetes.acponline.org/archives/2023/12/08/9.htm
8 Dec 2023
CBT device for type 2 diabetes receives OK to market
The FDA recently authorized marketing of a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy (CBT) to adult patients with type 2 diabetes.
https://diabetes.acponline.org/archives/2023/08/11/8.htm
11 Aug 2023
Bionic pancreas cleared for patients with type 1 diabetes
The new automated insulin dosing system, called the iLet Bionic Pancreas, is intended for use in patients ages 6 years and older with type 1 diabetes.
https://diabetes.acponline.org/archives/2023/06/09/8.htm
9 Jun 2023
Nearly 1.5 million insulin syringes recalled
Recalled syringes may have graduated markings that are printed incorrectly on the syringe barrel.
https://diabetes.acponline.org/archives/2021/07/09/8.htm
9 Jul 2021
Recall, expanded indication for different CGMs
Some sensors for the Freestyle Libre 3 continuous glucose monitor (CGM) were recalled, and an interoperable automated glycemic controller was approved for insulin-dependent type 2 diabetes.
https://diabetes.acponline.org/archives/2024/10/11/8.htm
11 Oct 2024
Two diabetes drugs go generic
A dipeptidyl peptidase-4 inhibitor and sodium-glucose cotransporter-2 inhibitor recently had first-time generic versions approved.
https://diabetes.acponline.org/archives/2023/11/10/9.htm
10 Nov 2023