Search results for "FDA update"


 
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Test strips recalled

The SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip may report falsely low blood glucose levels.
https://diabetes.acponline.org/archives/2016/03/11/8.htm
11 Mar 2016

New daily injection approved for adults with type 2 diabetes

Lixisenatide (Adlyxin), a once-daily injection, was approved by the FDA on July 28 to improve glycemic control in adults with type 2 diabetes.
https://diabetes.acponline.org/archives/2016/08/12/8.htm
12 Aug 2016

Insulin needles failing to deploy

Several lots of the OmniPod Insulin Management System were affected by a recent field safety notification about needle mechanisms failing to deploy or demonstrating a delay in deployment.
https://diabetes.acponline.org/archives/2015/12/11/7.htm
11 Dec 2015

Warning on risks of canagliflozin

The FDA on Sept. 10 released a strengthened warning on canagliflozin (Invokana, Invokamet) about increased risk of bone fractures and decreased bone mineral density.
https://diabetes.acponline.org/archives/2015/10/09/7.htm
9 Oct 2015

FDA clears marketing of first interoperable insulin pump

The pump can be used with various components of diabetes therapy systems, including automated insulin dosing systems, continuous glucose monitors, and blood glucose meters.
https://diabetes.acponline.org/archives/2019/03/08/7.htm
8 Mar 2019

Incretin mimetics' effects on pancreas under investigation

The FDA is investigating reports of possible increased risk of pancreatitis and precancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes.
https://diabetes.acponline.org/archives/2013/05/10/13.htm
10 May 2013

Single and combo diabetes drugs approved

Alogliptin (Nesina) and two new combination drugs (alogliptin and metformin hydrochloride [Kazano] and alogliptin and pioglitazone [Oseni]) were approved by the FDA to improve blood glucose control in adults with type 2 diabetes, along with diet and exercise.
https://diabetes.acponline.org/archives/2013/05/10/12.htm
10 May 2013

Warning on DPP-4 inhibitors and insulin recall

Dipeptidyl peptidase-4 (DPP-4) inhibitors may cause joint pain that can be severe and disabling, and some insulin pods may fail, the FDA recently warned.
https://diabetes.acponline.org/archives/2015/09/11/6.htm
11 Sep 2015

New weight loss device approved

A new balloon device (the ReShape Dual Balloon) was recently approved by the FDA to treat obesity without invasive surgery.
https://diabetes.acponline.org/archives/2015/08/14/6.htm
14 Aug 2015

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

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