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CPAP maker Phillips enters consent decree that stops company from selling machines

Sleep apnea machine maker Phillips formally entered into a consent decree stemming from recalled machines Tuesday. The machines were first recalled in 2021.

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Your Digital Health Regulation Questions Answered - Healthcare

The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD).

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Paul Gadiock Health Products Attorney at McDermott Will and Emery

Paul Gadiock Health Products Attorney at McDermott Will and Emery
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New FDA Guidance on AI and Medical Products | Troutman Pepper

New FDA Guidance on AI and Medical Products | Troutman Pepper
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Company Behind Defective CPAP Machines Must Make Changes Before U.S. Production Resumes

WEDNESDAY, April 10, 2024 (HealthDay News) -- Philips Respironics, the company responsible for the recall of millions of defective sleep apnea machines since 2021, must overhaul its production of the machines before it can resume making them in the United States, federal officials announced Tuesday. Under a settlement reached with the company, Philips must revamp

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Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines

Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines
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FDA Charts Course for Regulating AI Used in Medical Products | McDermott Will & Emery

On March 15, 2024, four of the US Food and Drug Administration’s (FDA) medical products centers released a joint paper, titled “Artificial Intelligence & Medical Products: How CBER,...

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Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines

The federal court entered a consent decree of permanent injunction against Philips Respironics following a recall of certain sleep therapy machines manufactured by the company.

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Consent Decree Finalized Against Philips Respironics

The consent decree, with limited exceptions, restricts the production and sale of new CPAPs, BiPAPs, and other devices at several Philips Respironics facilities in the United States until certain requirements are met.

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