FDA Roundup: November 15, 2024 [Yahoo! Finance]
GETINGE AB UNSP/ADR (GNGBY)
NASDAQ:AMEX Investor Relations:
getinge.com/int/about-us/investors
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Source: Yahoo! Finance
Next week, the World Health Organization's Member State Mechanism on Substandard and Falsified Medical Products will hold its 13th meeting in Geneva, Switzerland . Ahead of the Nov. 20-22 meeting, FDA Associate Commissioner Mark Abdoo , a vice-chair of the Mechanism's Steering Committee, published a blog on Nov. 7 on how to make the Mechanism more effective. Today, the FDA issued a Letter to Health Care Providers about safety concerns with Getinge/Maquet VasoView HemoPro Endoscopic Vessel Harvesting (EVH) Systems, and a supply concern for EVH devices. On Sept. 20, 2024 , Getinge/Maquet announced a voluntary recall for removal of all unused VasoView HemoPro 1.5 devices due to the risk of silicone detaching from the jaws of the harvesting tool during use. The removal of VasoView HemoPro 1.5 from use may interrupt the supply of EVH devices. The FDA has updated the medical device shortage list to include EVH devices (product code GEI). Acknowledging that alternative options are limited
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