Search results for "FDA update"

Results 1 - 10 of about 82 for "FDA update".
Sort by: Relevance | Newest | Oldest

Insulin pump approved for type 1 diabetes

The FDA recently approved the MiniMed 780G System for continuous delivery of basal insulin at selectable rates and the administration of insulin boluses at a selectable amount for the management of type 1 diabetes in patients ages 7 years and older requiring insulin.
12 May 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.
14 Apr 2023

FDA clears marketing of mobile app for automated insulin dosing in type 1 diabetes

The prescription-only mobile application is intended for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in persons ages 6 years and older.
10 Feb 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.
9 Dec 2022

Drug approved to delay onset of stage 3 type 1 diabetes

The first-in-class therapy, indicated in adults and pediatric patients ages 8 years and older who currently have stage 2 type 1 diabetes, is administered by IV infusion once daily for 14 consecutive days.
9 Dec 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.
14 Oct 2022

Nearly 1.5 million insulin syringes recalled

Recalled syringes may have graduated markings that are printed incorrectly on the syringe barrel.
9 Jul 2021

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.
14 Jan 2022

Insulin recalled due to potential missing label

Mylan Pharmaceuticals Inc. is recalling one batch of insulin glargine injection due to the potential for a missing label on some pens within a labeled carton.
11 Feb 2022

Extended-release metformin recalled due to impurity

After recommending that several manufacturers recall the diabetes drug due to excess levels of N-nitrosodimethylamine, the FDA is assessing whether the recalls will result in shortages.
12 Jun 2020

Result Page: Prev   1   2   3   4   5   6   7   8   9   Next