Medical Device Security

Philips agrees to $1.1 billion settlement following CPAP recalls

May 6, 2024 - Concluding ongoing class action and personal injury litigations, Philips announced it had reached an agreement through mediation under Judge Diane M. Welsh. The deal does not require Philips Respironics to admit fault or liability in the case; however, it does require them to make $1.1 billion in settlement payments. Since 2021, Philips Respironics...


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FDA Issues Three New Draft Guidance Documents for Medical Devices

by Veronica Salib

Last week, the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued three new draft guidances to alter the 510(k) program. According to a statement...