Philips takes ‘first steps’

AMSTERDAM – Philips has re-entered the CPAP market outside of the United States, says CEO Roy Jakobs.  

The company has “gradually” started serving new sleep therapy patients in several countries, now that 99% of registered devices have been remediated globally. 

“This is starting across the globe,” said Jakobs during a recent conference call to discuss the company’s financial results for the third quarter of 2023. “So, Japan is an important market for us that we are very strong in. We also started to re-enter China. We have Australia and Latin America, but also the EU. We are working through the process with every regulator across the globe.” 

In the United States, however, Philips is still in discussions with the U.S. Food and Drug Administration on the need for additional testing for recalled devices and with the U.S. Department of Justice on a consent decree to resolve issues related to the recall. 

Jakobs said Philips’ return to the CPAP market has been welcomed, with demand for devices still high in the wake of its recall. 

“They welcome competition in the market and, therefore, there is no special program of discounts or anything like that happening or needed for us to get back in place,” he said. “We have been out for some time, but the first steps back into the market, I would say, are encouraging.” 

Update: Additional testing 

“We have done very extensive testing with independent labs that came to the conclusion that no appreciable harm was done to patients, which is a very important outcome of that,” Jakobs said. “They have been looking into the data and now they have posed some additional questions and they're kind of currently defining exactly what they can supplement the data with to come to, hopefully, the same conclusions. We also share the same objective that we want to ensure that whatever is out there is patient-safe.” 

Update: Consent decree 

“I think this whole speculation on the timing of the CD and the progress of the CD creates a lot of unnecessarily ripple (effects), which is why we said, you know, we don't control the timeline and we will update you as soon as we know that the CD is done,” said Abhijit Bhattacharya, CFO. “So, I think we'd just like to leave it there.”