Philips will stop selling new sleep apnoea devices in the United States. The Eindhoven-based healthcare technology company announced this on Monday when publishing its annual figures.
In doing so, Philips reached a settlement with the US medical regulator FDA, for which the company already set aside EUR 363 million in the past quarter.
No admission of guilt
Philips does not acknowledge any fault or liability in that settlement with the FDA. The company has had to recall millions of sleep apnoea devices since 2021 because insulation foam could come loose, which can be harmful to patients’ health. The affair has already cost Philips hundreds of millions in compensation for the faulty machines.
According to Philips, the final terms of the settlement are still being worked on and will be submitted to a US court for approval. So until those terms are met, sales of new CPAP and BiPAP devices in the US market will be halted, the company said.
Statement
Philips will still continue to provide services in the US. This is for existing sleep apnoea and respiratory devices at healthcare providers and patients. “The decree will provide Philips Respironics with a roadmap with defined actions, milestones and outcomes to demonstrate compliance with regulatory requirements and restore business operations,” Philips reported in the statement.
Figures
The problems with sleep devices have plagued Philips for a long time. It is one of the reasons for the huge wave of redundancies the company declared early last year, including for the Eindhoven region. Over the whole of 2023, the company managed to reduce its loss to over EUR 450 million. Sales are now on the rise again.
Source: Studio040
Translated by: Shanthi Ramani
