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BioWorld - Sunday, March 26, 2023

CPAP

Home » Topics » Medical devices » CPAP
  • 11 11 philips headquarters amsterdam
    Dec. 27, 2022
    By Mark McCarty

    Philips says CPAP testing data still suggest no conspicuous health issues

    Continuous positive airway pressure (CPAP) devices made by Philips Respironics Inc. are still presumed by the U.S. FDA and other regulators to present a health hazard to patients, but the company’s latest data seem to suggest otherwise. In a Dec. 21 statement, the Royal Philips subsidiary said that testing suggests no appreciable harm to health related to particulate matter emissions from the polyester-based polyurethane (PE-PUR) foam in these devices, and that there is no evidence of long-term harm associated with volatile organic compounds (VOCs), both of which are conclusions with which the FDA may not agree.
  • Regulatory us fda hq
    March 14, 2022
    By Annette Boyle

    FDA slams Philips for slow CPAP recall, further boosting competitors’ positions

    The FDA issued a rare 518(a) Notification Order to Royal Philips NV last week that requires the company to take more aggressive measures to notify patients, physicians and distributors about the June 2021 class I recall of its continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) systems. The recall stemmed from health risks posed by the deterioration of the polyester-based polyurethane (PE-PUR) noise reducing foam in the equipment.
  • Newco idea hand holding lighbulb
    Sep. 16, 2021
    By David Godkin

    Startup Somne collars new solution for treating obstructive sleep apnea

    Newly launched startup Somne Inc. plans to give CPAP machines a run for their money by replacing CPAP masks and hoses for treating obstructive sleep apnea with a gentler collar encircling the patient’s neck. The new device uses variable negative pressure to ensure users get a good night’s sleep instead of positive airway pressure employed by companies such as Resmed Inc. and Philips Respironics Inc.
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