Search results for "FDA update"


 
Results 31 - 40 of about 71 for "FDA update".
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FDA recommends transition to duodenoscopes with disposable endcaps

While a full transition away from conventional duodenoscopes to innovative models will take time, health care facilities should develop plans to transition away from older models that have fixed endcaps, the FDA said.
https://gastroenterology.acponline.org/archives/2019/09/27/7.htm
27 Sep 2019

Ranitidine recalled due to detection of impurity

In response to the detection of N-nitrosodimethylamine, a probable carcinogen, several companies have recalled the histamine H2 receptor antagonist, although FDA testing has found that levels detected are low.
https://gastroenterology.acponline.org/archives/2019/11/22/6.htm
22 Nov 2019

Incontinence management system recalled due to potential interference with other devices

About a month after issuing an urgent medical device correction, the manufacturer announced a class I recall of the WatchCare Incontinence Management System due to potential radio frequency interference with other medical devices.
https://gastroenterology.acponline.org/archives/2022/12/23/8.htm
23 Dec 2022

Drug cleared to treat moderately to severely active ulcerative colitis

It is the first oral medication to be approved for chronic use in this population.
https://gastroenterology.acponline.org/archives/2018/06/22/6.htm
22 Jun 2018

FDA sends warning to duodenoscope manufacturers

The manufacturers have not fulfilled requirements to conduct studies assessing the real-world effectiveness of device reprocessing, the FDA said.
https://gastroenterology.acponline.org/archives/2018/03/23/6.htm
23 Mar 2018

IBS-D drug should not be prescribed to patients without gallbladders

The FDA suggests that clinicians should consider alternatives to eluxadoline in this population.
https://gastroenterology.acponline.org/archives/2017/03/24/8.htm
24 Mar 2017

New HCV drug combo approved

The fixed-dose tablet combines the previously approved drugs sofosbuvir and velpatasvir with a new drug, voxilaprevir.
https://gastroenterology.acponline.org/archives/2017/07/28/10.htm
28 Jul 2017

Regorafenib now FDA-approved to treat hepatocellular carcinoma

Approved use of the drug has been expanded to include treatment of patients with hepatocellular carcinoma who have been treated with sorafenib.
https://gastroenterology.acponline.org/archives/2017/05/26/7.htm
26 May 2017

Drug for chronic idiopathic constipation approved

The oral medication is taken once per day and works in the upper GI tract to stimulate secretion of intestinal fluid, supporting regular bowel function.
https://gastroenterology.acponline.org/archives/2017/01/27/7.htm
27 Jan 2017

Marketing authorized for endoscopic sleeve gastroplasty systems

The systems are the first to be authorized by the FDA for the minimally invasive weight-loss procedure, which is intended for adults with obesity who have not been able to lose weight or maintain weight loss through measures such as diet and exercise.
https://gastroenterology.acponline.org/archives/2022/08/26/12.htm
26 Aug 2022

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