Search results for "FDA update"

Results 1 - 10 of about 71 for "FDA update".
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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.
23 Dec 2022

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.
18 Nov 2022

Another warning for endoscope manufacturer after facility inspection in Japan

The warning letter to Olympus Medical Systems Corporation followed previous warning letters issued to the firm and one of its subsidiaries and described numerous violations, including failure to evaluate and report user reports of adverse events.
21 Apr 2023

First oral treatment approved for moderate to severe Crohn's disease

Upadacitinib (Rinvoq) is now approved to treat adult patients with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.
26 May 2023

FDA approves first fecal microbiota product

The product, which is prepared from donated, tested stool and administered rectally as a single dose, is indicated for the prevention of recurrent Clostridioides difficile infection in adults who have already completed antibiotic treatment for a recurrence.
23 Dec 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.
23 Sep 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.
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.
23 Sep 2022

More laxatives recalled due to microbial contamination

Recalled products were distributed nationwide at CVS drugstore locations.
22 Jul 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.
24 Jun 2022

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