Search results for "FDA update"


 
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Urgent medical device correction for incontinence management system

There is a potential for radio frequency interference between the WatchCare Incontinence Management System and other medical devices in the vicinity, such as insulin pumps, telemetry devices, and infusion injection pumps.
https://gastroenterology.acponline.org/archives/2022/11/18/10.htm
18 Nov 2022

FDA approves first medication for adults with hepatorenal syndrome

The treatment is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
https://gastroenterology.acponline.org/archives/2022/09/23/11.htm
23 Sep 2022

Hepatic artery infusion pumps recalled

The recall was initiated after reports from clinicians that the pumps were delivering medications faster than expected.
https://gastroenterology.acponline.org/archives/2022/09/23/12.htm
23 Sep 2022

More laxatives recalled due to microbial contamination

Recalled products were distributed nationwide at CVS drugstore locations.
https://gastroenterology.acponline.org/archives/2022/07/22/10.htm
22 Jul 2022

Monkeypox may be transmitted through fecal microbiota transplantation

Because of this risk, the FDA determined that additional protections are required for any investigational use of fecal microbiota transplantation if it involves stool donated on or after March 15, 2022.
https://gastroenterology.acponline.org/archives/2022/09/23/10.htm
23 Sep 2022

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

FDA approves first treatment for eosinophilic esophagitis

The monoclonal antibody is indicated to treat the chronic immune disorder in adults and pediatric patients ages 12 years and older who weigh at least 40 kg.
https://gastroenterology.acponline.org/archives/2022/05/27/9.htm
27 May 2022

Use duodenoscopes that are fully disposable or have disposable components, FDA recommends

Interim results from one duodenoscope model with a removable component showed a contamination rate of 0.5%, compared with as high as 6% among older duodenoscope models, an FDA safety communication noted.
https://gastroenterology.acponline.org/archives/2022/04/22/11.htm
22 Apr 2022

Laxatives and antacids recalled due to microbial contamination

The recall includes several lots of milk of magnesia and magnesium hydroxide/aluminum hydroxide/simethicone sold to clinics and hospitals nationwide.
https://gastroenterology.acponline.org/archives/2022/06/24/9.htm
24 Jun 2022

Laxative recalled due to potential microbial contamination

A company recently recalled one lot of senna syrup, which was distributed to a wholesaler, due to potential microbial contamination.
https://gastroenterology.acponline.org/archives/2022/01/28/6.htm
28 Jan 2022

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