Olympus is promising swift action to address concerns raised by the Food and Drug Administration (FDA) about some of its ...

Olympus announced recently that it is committed to addressing the concerns of the FDA around its device manufacturing in ...

Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal ...

Flexible bronchoscope (FOB) is commonly used nowaday for airway observation in lung diagnosis because of its easier, safer, and good tolerant technique. However, during intubation, FOB may lead to get ...

The FDA has barred the import of multiple medical devices manufactured by Olympus Medical Systems and its subsidiaries in Japan, citing ongoing violations of federal quality system regulations.

The standard pediatric bronchoscope has an outer diameter of 3.4 to 3.6 mm (depending on the manufacturer) with a suction channel of 1.2 mm. Specific information about the bronchoscopes used in ...

There have been no untoward risks reported in the series utilizing autofluorescence bronchoscopy. Considering that fluorescence inspection simply uses light of a different wavelength and that ...

The FDA is shutting the door to imports of certain endoscope hardware manufactured by Olympus, saying that a production site ...

The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System regulation violations by Olympus.” ...