Tag: Ventilator

WASHINGTON – With an “absurd” denial rate as high as 86% for non-invasive ventilators for one major Medicare Advantage plan, industry stakeholders are collaborating with patient advocacy groups to elevate their concerns with CMS.  Confusion around who qualifies for NIVs vs. bi-level devices is nothing new, but recently, it’s gotten worse, says David Chandler, senior director of payer relations for AAHomecare.  “It’s escalated to what I consider...

CLEVELAND – Medical Service Company has acquired OhioHealth Home Medical Equipment in Central Ohio.  “Through its three community locations and several in-hospital offices and liaisons, OhioHealth HME supports lightning-fast discharges for the OhioHealth hospital network,” MSC stated in a press release.  MSC has also entered a long-term partnership with the OhioHealth health system, which comprises a family of 35,000 associates, physicians and volunteers, and a network...

DEERFIELD, Ill. – Baxter International has issued an urgent medical device correction for the Life2000 ventilation system due to the potential for patient oxygen desaturation (low blood oxygen) events that may occur under certain conditions when the system is connected with a third-party oxygen concentrator. Low oxygen saturation may lead to symptoms like shortness of breath, confusion, rapid heart rate or bluish skin. Among the most vulnerable patients, death, life-threatening events or permanent...

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 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...

AUSTIN, Texas - Movair, a respiratory therapy company formerly known as International Biophysics Corporation, has launched Luisa, an advanced ventilator intended for use in homes, institutions, hospitals or portable applications for both invasive and non-invasive ventilation. Luisa can be used through the FDA's Emergency Use Authorization in response to the increasing need for safe and effective ventilators. "Increased respiratory patient illness, COVID-19 and product recalls have created a critical...

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 – 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...

LAFAYETTE, La. – Viemed Healthcare grew its core business by 21% in 2020 and rolled out several new programs in the fourth quarter that will enhance and diversify the company’s overall business in 2021, says CEO Casey Hoyt.  For one, the company has moved from pilots to national rollouts of both its “Engage” and “View” platforms, which...

LAFAYETTE, La. – Viemed Healthcare has published a study that shows non-invasive ventilation at home improves survival and decreases health care utilization in Medicare beneficiaries with COPD with chronic respiratory failure.  “This study is the first of its kind published in the U.S. and represents a significant milestone in our mission of educating the medical community on the benefits of NIVH,” said Casey Hoyt, Viemed CEO. “The data supports...