Search results for "FDA update"
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
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
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
Safety alert and advice on CT scanning in patients with insulin pumps
The presence of an insulin pump should not preclude an appropriate and medically indicated CT scan, the FDA said.
https://diabetes.acponline.org/archives/2016/04/08/6.htm
8 Apr 2016
New indication approved for empagliflozin
Empagliflozin (Jardiance) is approved for a new indication—to reduce the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease.
https://diabetes.acponline.org/archives/2016/12/09/6.htm
9 Dec 2016
Continuous glucose monitoring system approved to direct therapy, but daily fingersticks still needed
The G5 Mobile Continuous Glucose Monitoring System is now approved for patients and clinicians to use results directly from the device to make diabetes treatment decisions.
https://diabetes.acponline.org/archives/2017/01/13/8.htm
13 Jan 2017
Insulin, other biologics gain new pathway for biosimilars
The FDA expects that the regulatory transition, mandated by Congress, will support market competition and increase patient access to these drugs.
https://diabetes.acponline.org/archives/2020/04/10/9.htm
10 Apr 2020
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.
https://diabetes.acponline.org/archives/2020/06/12/9.htm
12 Jun 2020
Do not use unauthorized devices for diabetes management, FDA warns
Use of such devices, either alone or with authorized devices, could result in inaccurate glucose level readings or unsafe insulin dosing, potentially leading to death or injury.
https://diabetes.acponline.org/archives/2019/06/14/7.htm
14 Jun 2019
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