DreamStation 2 safety warning could delay Philips returning to the market
On 28 Nov 2023, the FDA issued a safety communication warning to users of Philips' Dreamstation 2 devices that their devices could overheat. The FDA has received 270 Medical Device Reports (MDRs) between 1 Aug 2023 and 15 Nov 2023 of thermal issues such as fire, smoke, burns and other signs of overheating (vs 30 MDRs in the previous 3 years)
From RBC Capital Markets:
We believe this issue for Philips' CPAP devices could further delay the finalisation of its Consent Decree and therefore lead to an extension of its time out of the new patient market in the US. We currently assume Philips returns to the Americas new patient market during the Sep 24 qtr, and therefore any delay to the finalisation of Philips’ Consent Decree could lead to higher devices sales for RMD. This new overheating issue for DreamStation 2 devices may also impact Philips' sales to new patients in markets outside the US, which could also lead to higher device sales for RMD in RoW markets
DISC: Held in SM & RL