Search results for "FDA update"
Liraglutide gets new cardiovascular indication
The FDA approved a new indication for liraglutide to reduce the risk of myocardial infarction, stroke, and cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
https://diabetes.acponline.org/archives/2017/09/08/8.htm
8 Sep 2017
CGM system approved for use without finger sticks
A continuous glucose monitoring (CGM) system was approved and some infusion sets were recalled, the FDA recently announced.
https://diabetes.acponline.org/archives/2017/10/13/6.htm
13 Oct 2017
Metformin solution recalled due to contamination
Two lots of metformin hydrochloride oral solution (Riomet), 500 mg/5 mL, were recalled due to fungal contamination, the FDA said.
https://diabetes.acponline.org/archives/2017/12/08/7.htm
8 Dec 2017
Ertugliflozin approved as adjunct treatment for type 2 diabetes
As an adjunct to diet and exercise, the drug was approved as monotherapy and for use in fixed-dose combinations with metformin or sitagliptin.
https://diabetes.acponline.org/archives/2018/01/12/7.htm
12 Jan 2018
Follow-on insulin lispro approved
The injection is approved to improve glucose control in patients ages three years and older with type 1 diabetes and in adult patients with type 2 diabetes.
https://diabetes.acponline.org/archives/2018/01/12/8.htm
12 Jan 2018
Device approved to treat diabetic foot ulcers
The shock-wave system is intended to be used with standard diabetic ulcer care in patients ages 22 years and older with ulcers lasting more than 30 days.
https://diabetes.acponline.org/archives/2018/01/12/6.htm
12 Jan 2018
First continuous glucose monitoring system approved to be used with other devices
The system is the first approved to be used with other diabetes devices, such as automated insulin-dosing systems, insulin pumps, or blood glucose meters, according to the FDA.
https://diabetes.acponline.org/archives/2018/04/13/6.htm
13 Apr 2018
First AI device approved to detect diabetes-related eye problems
The software analyzes images of the eye taken with a retinal camera and offers one of two results: “more than mild diabetic retinopathy detected: refer to an eye care professional” or “negative for more than mild diabetic retinopathy; rescreen in 12 months.”
https://diabetes.acponline.org/archives/2018/05/11/6.htm
11 May 2018
First continuous glucose monitoring system with fully implantable glucose sensor approved
The sensor is coated with a fluorescent chemical that produces a small amount of light when exposed to blood glucose. Every five minutes, it sends glucose measurements to a compatible device that is running a device-specific mobile app.
https://diabetes.acponline.org/archives/2018/07/13/10.htm
13 Jul 2018
New warnings for fluoroquinolones about risk of hypoglycemic coma
The labeling changes for fluoroquinolones will also make the mental health side effects more prominent and more consistent across the drug class.
https://diabetes.acponline.org/archives/2018/08/10/9.htm
10 Aug 2018