Sam Brusco, Associate Editor01.29.24
Philips said that it will not sell new CPAP or BiPAP sleep therapy devices in the U.S. for the next few years based on the terms of a consent decree with the U.S. Department of Justice (DOJ) representing the U.S. Food and Drug Administration (FDA).
This agreement followed the recall of millions of Philips Respironics breathing devices and ventilators for sleep apnea in 2021 due to concerns about its sound abatement foam degrading and becoming toxic, with potential risks of cancer.
The consent decree is currently being finalized. It will provide the company with a plan of action, milestones, and deliverables to show compliance with regulatory requirements and to reinstate the business. Philips will continue to service devices already in circulation but no new devices will be sold in the U.S., the company said.
“Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and I acknowledge and apologize for the distress and concern caused,” Philips CEO Roy Jakobs told the press. “We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.”
New sleep and respiratory devices will still be sold outside of the U.S. Philips put aside €363 million in Q4 2023 for the costs of the agreement.
The company said the agreement didn’t alter its financial targets for 2025. The company expects 3-5% comparable sales growth and Adjusted EBITA margin of 11-11.5% for the full-year 2024.
This agreement followed the recall of millions of Philips Respironics breathing devices and ventilators for sleep apnea in 2021 due to concerns about its sound abatement foam degrading and becoming toxic, with potential risks of cancer.
The consent decree is currently being finalized. It will provide the company with a plan of action, milestones, and deliverables to show compliance with regulatory requirements and to reinstate the business. Philips will continue to service devices already in circulation but no new devices will be sold in the U.S., the company said.
“Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and I acknowledge and apologize for the distress and concern caused,” Philips CEO Roy Jakobs told the press. “We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.”
New sleep and respiratory devices will still be sold outside of the U.S. Philips put aside €363 million in Q4 2023 for the costs of the agreement.
The company said the agreement didn’t alter its financial targets for 2025. The company expects 3-5% comparable sales growth and Adjusted EBITA margin of 11-11.5% for the full-year 2024.