Editorial and Omrop Braband
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Philips Stops Selling New Sleep Apnea Devices in US The Eindhoven-based healthcare technology company first announced this on Monday when it released its annual figures.
Philips has reached a settlement with the FDA, the US medical regulator, for which the company already allocated 363 million euros last quarter.
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Philips has not admitted any wrongdoing or liability in this settlement with the FDA. The company had to recall millions of sleep apnea devices starting in 2021 because the insulation foam could loosen, harming patients' health. The issue has already cost Philips hundreds of millions in compensation for the defective machines.
According to Phillips, the final terms of the settlement are still being finalized and will be submitted to the US court for approval. Until those conditions are met, sales of new CPAP and BiPAP devices in the U.S. market will be halted, the company said.
Philips will continue to provide healthcare providers and patients with services for existing sleep apnea and respiratory devices in the United States. “This order will enable Philips Respironics to demonstrate compliance with regulatory requirements and restore business operations with defined actions, milestones and results,” Philips said in the statement.
Problems with sleep devices have long troubled Philips. This is also one of the reasons for the massive wave of layoffs the company announced early last year for the Eindhoven region. The company managed to reduce losses by more than 450 million euros for the whole of 2023. Now the turnover has increased again.
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