Continuous positive airway pressure (CPAP) devices made by Philips Respironics Inc. are still presumed by the U.S. FDA and other regulators to present a health hazard to patients, but the company’s latest data seem to suggest otherwise. In a Dec. 21 statement, the Royal Philips subsidiary said that testing suggests no appreciable harm to health related to particulate matter emissions from the polyester-based polyurethane (PE-PUR) foam in these devices, and that there is no evidence of long-term harm associated with volatile organic compounds (VOCs), both of which are conclusions with which the FDA may not agree.
The FDA issued a rare 518(a) Notification Order to Royal Philips NV last week that requires the company to take more aggressive measures to notify patients, physicians and distributors about the June 2021 class I recall of its continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) systems. The recall stemmed from health risks posed by the deterioration of the polyester-based polyurethane (PE-PUR) noise reducing foam in the equipment.
Newly launched startup Somne Inc. plans to give CPAP machines a run for their money by replacing CPAP masks and hoses for treating obstructive sleep apnea with a gentler collar encircling the patient’s neck. The new device uses variable negative pressure to ensure users get a good night’s sleep instead of positive airway pressure employed by companies such as Resmed Inc. and Philips Respironics Inc.
Like so many other ventilator providers in recent days, Resmed Inc. has committed to ramping up production. It aims to triple its ventilator output and multiply its ventilation mask production by 10. But the San Diego-based company’s specialty is not mechanical ventilation that requires intubation, which is most commonly used in the intensive care unit (ICU), although it does produce some of those.
It was a standout quarter for San Diego-based Resmed Inc., which saw revenues jump to $681.1 million, with the U.S., Canada and Latin America serving as bright spots. "We have started fiscal year 2020 right where we left off with 2019," Michael Farrell, Resmed's CEO, said during a call on the results. "Our team achieved another quarter of the balanced growth across the portfolio, driven by continued strong performance in the mask category."