ResMed Inc.

ASX:RMD

ResMed Inc.

ASX:RMD
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$32.75 (-0.3%)
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Pinned straw:
Remorhaz
Last edited 7 months ago

Just published in a note from by Morgan Stanley

Clear pathway for RMD for longer 

The FDA Center for Devices and Radiological Health (CDRH) has provided an update on the Philips June 2021 recall. At the FDA’s request, Philips (PHG.AS, covered by Robert Davies) had completed an independent testing program to assess the risks related to the PE-PUR sound abatement foam found in certain recalled Philips devices

Notably, the FDA has concluded that “We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices. Although Philips concluded that the exposure to foam particles and VOCs from these devices is "unlikely to result in an appreciable harm to health in patients," the FDA believes additional testing is necessary”. Philips has agreed to conduct the requested additional testing

Philips remains in discussion with the US DOJ on the terms of its consent decree to resolve the identified issues with its manufacturing practices. No timeline has been outlined. The company previously guided to a Q2 consent decree finalisation


DISC: Held in RL & SM
Remorhaz
6 months ago

Morgan Stanley have just released a new update on this (potential impact from Philips)

Philips (covered by Robert Davies) reported 3Q23 results. Key takeaways:

(i) Philips stated remediation of >99% of sleep therapy devices completed while remediation of ventilators remains ongoing. To date, ~4.7mn devices have been remediated globally, of which 2.5mn are in the US. Philips expects to remediate up to 5.6mn devices, of which more than half are in the US

(ii) Philips stated “FDA has requested, and Philips Respironics has agreed to implement additional testing to supplement current test data. The FDA has not expressed concern with the validity or objectivity of the testing done to date. Philips Respironics is in discussions with the FDA on the details of further testing.” Of the information disclosed thus far, additional testing looks to be completed on Trilogy and OmniLab devices which represent ~5% of registered devices

(iii) Discussions with US Department of Justice on a proposed consent decree are ongoing

(iv) PHG has started serving new patients with sleep therapy devices outside the US

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