Philips Finalizes Sleep Apnea Consent Decree With FDA (1)

The consent decree between Philips and the US Food and Drug Administration over its faulty sleep apnea devices has been submitted to a US court for approval on April 4, according to an emailed statement by the company.

• The consent decree focuses on Philips Respironics’ operations in the US
  • Once approved, the decree will provide the unit in the US, which generated €1 billion sales in 2023, with a roadmap of deliverables to prove compliance with regulatory requirements and to restore the business, Philips spokesperson Steve Klink says
  • “With the clarity that we now have with the consent decree ...