Vendors

AMSTERDAM – Philips could hear back from the U.S. Food and Drug Administration in August about its plans to replace the foam in certain CPAP devices and ventilators, based on a timeline provided during the company’s July 26 conference call to discuss financial results for the second quarter.  Philips filed "multiple packages" of CFR 806 applications for corrections and removals with the FDA in June and CEO Frans van Houten said, based on prior experience, there’s typically...

AMSTERDAM – Philips reported a 16% decline in sales for its Connected Care business, which includes Sleep and Respiratory Care, for the second quarter of 2021 compared to the same period last year, in the wake of a massive recall of certain CPAP devices and ventilators.  Mid-single-digit growth in Hospital Patient Monitoring was more than offset by a double-digit decline in Sleep & Respiratory Care, the company says.  “We have mobilized the necessary resources across the...

AMSTERDAM – The U.S. Food and Drug Administration has classified the voluntary recall of certain Philips CPAP devices and ventilators as Class I.   The FDA defines Class I as “a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”  The agency posted recalls for the various affected devices, along with their classification, to its database on July 13 and July...

IRVING, Texas – McKesson has entered into an agreement to sell its European businesses in France, Italy, Ireland, Portugal, Belgium and Slovenia to the PHOENIX group. McKesson’s remaining European businesses in the U.K., Norway, Austria and Denmark are not part of the transaction, but the company says it is “exploring strategic alternatives” for those businesses, as it shifts the focus of future investments outside of Europe. “This transaction marks an important...

THEODORE, Ala. – Supreme Medical Fulfillment has launched a new online ordering portal with real-time inventory to help its provider customers better respond to everything from the COVID-19 pandemic to supply chain challenges.  “Some portals will say a product is available or that it’s in stock,” said Colton Mason, senior vice president. “We found providers didn’t want to know that; they wanted to know if we had six or 60. Now when they’re placing...

SAN DIEGO – ResMed says a draft technology assessment that shows published studies mostly do not support that CPAP therapy affects long-term clinical health outcomes bypasses “a generation of data in real-world evidence.”  The company submitted comments on the 155-page assessment, presenting peer-reviewed and published data that show CPAP therapy improves quality of life, reduces health care costs and even reduces mortality. The data show a reduction in the incidences of...

YARMOUTH, Maine – Manufacturers like ResMed and 3B Medical are ramping up production to meet increased demand due to a voluntary recall of millions of Philips CPAP devices, but their efforts are complicated by supply chain and other challenges.  “Yes, we’re ramping up production as quickly as possible, while working closely with our global supplier network to navigate the well-known global supply chain challenges impacting this and other industries,” said Jayme...

MANHATTAN BEACH, Calif. – BodiMetrics is ramping up exposure for its CIRCUL Sleep & Fitness Ring by partnering with VGM & Associates and exploring an advertising campaign in Prevention Magazine.  The Ring, which is Bluetooth-connected to a user’s smart phone, can be used for everything from tracking overnight sleep to monitoring daytime SpO2 and heart rate to recording workouts, making it ideal for monitoring CPAP and other therapies, says Jim Gilkison, vice president of sales.  “It’s...

PETERSBOROUGH, N.H. – SoClean is standing by its CPAP cleaning device, after Philips said “unapproved cleaning methods, such as ozone,” may be exacerbating the degradation of sound abatement foam in its first-generation DreamStation product family.   Philips made the claim as part of a voluntary recall announced June 14 to address identified potential health risks related to the polyester-based polyurethane foam in certain Bi-Level CPAP, CPAP and mechanical ventilator...

AMSTERDAM – Royal Philips has announced, in consultation with regulatory agencies, a voluntary recall notification on certain Bi-Level CPAP, CPAP and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane sound abatement foam component in these devices.  The majority of affected devices within the advised five-year service life are in the first-generation DreamStation product family, the company says.  “We...