Philips shares slump as FDA says sleep product may overheat

By Steve Goldstein

Vivos Therapeutics stock surges

Phillips shares fell sharply Wednesday as the Food and Drug Administration said there's an emerging safety issue involving its product for sleep apnea.

The FDA said the issue is with the DreamStation 2 Continuous Positive Airway Pressure machines used for treatment of obstructive sleep apnea. The FDA said there are medical device reports showing "fire, smoke, burns and other signs of overheating while using the machine."

The FDA has previously criticized the company for its handling of the June 2021 recall of millions of sleep therapy and respirator machines. The recalled machines use polyester-based polyurethane foam, while the DreamStation 2 machines are manufactured with a silicone-based foam.

The FDA said the DreamStation 2 issue is not related to the foam but possibly related to an electrical and/or a mechanical malfunction. A message left with Philips wasn't immediately returned.

Philips shares (NL:PHIA) (PHG) dropped 4% but have gained 40% this year.

Vivos Therapeutics (VVOS), which said it's won FDA approval for an alternative treatment to CPAP, saw its stock jump 145% in early action.

-Steve Goldstein

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11-29-23 0948ET

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