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Keyword: sleepapneadevices

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  • Philips’ U.S. sales of sleep apnea devices face years-long halt after FDA deal

    01/29/2024 2:33:16 PM PST · by ducttape45 · 82 replies
    CNBC ^ | 1/29/2024 | Reuters
    Dutch health technology company Philips will not sell new devices to treat sleep apnea in the U.S. in the coming years as it works to comply with a settlement with the Food and Drug Administration (FDA) announced on Monday. The agreement followed the recall of millions of breathing devices and ventilators used to treat sleep apnea in 2021 because of concerns that foam used to reduce noise from the devices could degrade and become toxic, carrying potential cancer risks. Philips said it had reached what is known as a consent decree that spells out the improvements it needs to make...