Search results for "FDA update"
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