Tag: CPAP Devices

ORLANDO, Fla. – OxyGo, a supplier of portable oxygen concentrators, has launched a new sleep line. OxyGo SLEEP offers a full line of products, including CPAP and BPAP devices, travel batteries, sanitizers and accessories, as well as a web-based compliance portal for managing patient devices. “Launching a portal that will allow providers to communicate stats and share data with other health care professionals is key to making the user experience better for both sleep providers and patients,”...

YARMOUTH, Maine – CPAP providers are seeing a slow rebound in business as a chokehold on orders for devices eases up, but they continue to see increased costs.  For more than a year, providers have juggled the challenges of a recall of certain CPAP devices by Philips and a subsequent shortage of available devices on the market with overall supply chain challenges affecting all manufacturers.  “Looking at my numbers from April to August, we’ve set up more CPAPs during...

YARMOUTH, Maine – Treatment with CPAP devices was better than mandibular advancement devices at normalizing polysomnographic parameters and improving quality of life in patients with mild obstructive sleep apnea, according to a recent study published in Sleep Breathing Physiology and Disorders. Fatigue was improved in both CPAP and MAD groups, and daytime sleepiness, mood and sustained attention showed no difference. This study was a single-blind, parallel, randomized clinical trial with controls....

WASHINGTON – The U.S. Food and Drug Administration updated its safety communication for the Philips recall this month, saying it received more than 48,000 medical device reports, including 44 reports of death, associated with the foam breakdown or suspected foam breakdown in certain CPAP devices from May 1, 2022, through July 31, 2022.  The agency previously reported in May that it received more than 21,000 MDRs, including 124 reports of death, associated with the foam breakdown...

WASHINGTON – The U.S. Food and Drug Administration says it received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the foam breakdown or suspected foam breakdown of recalled Philips BiPAP and CPAP devices. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers and patients. A wide range of injuries were reported in the MDRs, including cancer, pneumonia, asthma, other respiratory...

SAN DIEGO – ResMed reported revenue increased 12% to $864.5 million in its third quarter fiscal year 2022. The company reported revenue, excluding software-as-a-service, increased 18% in the United States, Canada and Latin America, primarily due to a recall by one of its competitors and a recovery of core sleep patient flow that has been impacted by the COVID-19 pandemic. “Our third-quarter results reflect strong performance across our business, resulting in double-digit top-line...

WASHINGTON – The U.S. Food and Drug Administration says efforts by Philips Respironics to notify patients and others of its recall of certain ventilators and CPAP and BiPAP devices and the risk of harm from the polyester-based polyurethan (PU-PUR) sound abatement foam used in those products have been “inadequate.”  The FDA on March 10 issued a notification order to Philips Respironics requiring the company to notify all device users, DME suppliers, distributors, retailers,...

AMSTERDAM, the Netherlands – Philips expects to share additional research and test data on patient risk from recalled CPAP devices and ventilators in the fourth quarter.  The company recalled certain devices, including the first-generation DreamStation CPAP devices, in June to address potential health risks related to the polyester-based polyurethane sound abatement foam component in these devices.  “When we announced the recall, we acted on the assumption of a worst-case...

AMSTERDAM, the Netherlands – Philips reported EUR 4.2 billion in group sales for the third quarter, a 7.6% comparable decline due to headwinds caused by global supply chain challenges and the recall of certain CPAP devices and ventilators.  The company says comparable sales decreased 39% for its Connected Care business, following, in part, a double-digit decline in Sleep & Respiratory Care in the third quarter.  “This quarter’s sales were impacted unfavorably...

AMSTERDAM, the Netherlands – Royal Philips has received authorization from the U.S. Food and Drug Administration to begin replacing the sound abatement foam with new material in certain sleep and respiratory care devices starting this month.  The company has also started replacing certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices, which aren’t affected by the recall.  “We fully recognize...