medtechdive7d
FDA labels recall of discontinued Olympus endoscope part as Class I
The update comes about six weeks after an early alert flagged reports of 120 injuries and one death linked to reprocessing of ...
Modern Healthcare29d
How medical device reprocessing can save hospitals millions
An agency directive bans the use of FDA-regulated reprocessing services that involve collecting and buying back single-use devices. A spokesperson pointed to concerns the Joint Commission and the ...
Yahoo Finance9d
FDA labels recall of discontinued Olympus endoscope accessory as Class I
In recent years, Olympus has recalled other devices because of patient safety risks and received three FDA warning letters related to its endoscopes. Safety concerns associated with the reprocessing ...
BioSpace14d
Olympus Issues Medical Device Advisory Notice to Use Alternative Devices to the MAJ-891 Forceps/Irrigation Plug
The potential harm of improper and/or incomplete reprocessing of the MAJ-891 Forceps/Irrigation Plug is exposure to a contaminated device ... problems experienced with the use of these products may be ...
USA Today15d
Olympus Issues Medical Device Advisory Notice to Use Alternative Devices to the MAJ-891 Forceps/Irrigation Plug
model MAJ-891 related to the risk of device contamination that may result from improper reprocessing of the MAJ-891 accessory.
pharmaphorum3d
FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials
Similar signs of growth can be seen in the amount of drugs, biologics and medical devices the country exports to the US. The US FDA ... over the use of clinical trial data from a single foreign ...
U.S. FDA approves Supernus' drug-device combination for Parkinson's disease
The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals' drug-device combination to treat ...
Local 12 WKRC Cincinnati6d
FDA clears migraine device for children as young as 8
The device was recently cleared by the FDA for use in children as young as eight to alleviate headaches due to migraines. Savannah described the device's effectiveness. "I can just wear it for 45 ...