Philips targets innovation, trust 

AMSTERDAM – In a key post-recall milestone, Philips says it has more than doubled its number of 510(k) clearances from the U.S. Food and Drug Administration (FDA) over the past two years. 

During a recent conference call to discuss fourth quarter and full-year financial results, Roy Jakobs reiterated that Philips continues “to address the consequences of the Respironics recall” and “relentlessly work toward resolution of the FDA warning letter issued last October.” 

“We integrally designed new innovations and act fast and comprehensively when improvement opportunities arise,” said Jakobs, president and CEO. “This reflects a simpler, more standardized quality system that embeds patient impact and quality at design stage, enabling high-quality innovation to support patients at scale.” 

Philips returned to most global markets for CPAP devices in late 2023, with the U.S. an exception. 

Philips works to rebuild trust in sleep 

Philips reported comparable sales for its Connected Care segment – which includes Sleep & Respiratory Care (SRC) – increased 7% in the fourth quarter and 3% for the full year. Much of the discussion during the call, however, centered on non-SRC categories such as monitoring and enterprise informatics solutions. 

In a Capital Markets Day presentation held the same day, Philips highlighted its plan to expand its sleep and respiratory mask portfolio as part of its 2026–28 growth pipeline. The company also outlined its goal “to restore business trust, position and profitability” for SRC. Philips currently estimates it is the No. 2 player in both sleep therapy devices and masks. 

Possible changes ahead for tariffs on imported medical equipment 

When asked about the U.S. Department of Justice’s Section 232 investigation – an inquiry into potential national security risks associated with imported medical equipment – Jakobs said he could not comment on what the outcome may be.  

“The 232 investigation has not been concluded nor any outcome shared,” he said. “How we look at it is that, in essence, it's equal to tariffs, but a different way of going after it, right? So, I think this is a potential measure that could replace tariffs. So, we don't think this will worsen the situation. It could potentially actually improve the situation, but we don't speculate on that. We are, of course, actively engaged. We also are part of the discussion.”