Search results for "FDA update"
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
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
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
Diabetes device recalled due to risk of fire
The FDA recently announced a class I recall of the Omnipod DASH Insulin Management System Personal Diabetes Manager due to reports of battery issues, including battery swelling, fluid leakage, and extreme overheating that may pose a fire hazard.
https://diabetes.acponline.org/archives/2022/12/09/10.htm
9 Dec 2022
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
New safety alert for certain continuous glucose monitoring systems
Glucose readers in the FreeStyle Libre product family have the potential for battery swelling and overheating if not properly stored, charged, or used.
https://diabetes.acponline.org/archives/2023/04/14/7.htm
14 Apr 2023
More metformin recalled due to nitrosamine impurity
The recall includes 33 lots of metformin hydrochloride extended-release tablets USP (750 mg) manufactured in India and distributed in the U.S.
https://diabetes.acponline.org/archives/2022/01/14/6.htm
14 Jan 2022
Alert warns about cybersecurity risk with insulin pump system
A potential issue with the Medtronic MiniMed 600 Series Insulin Pump System's communication protocol could allow unauthorized access to the device, the FDA said.
https://diabetes.acponline.org/archives/2022/10/14/9.htm
14 Oct 2022