Tag: FDA

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...

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 – 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...

WASHINGTON – VGM has asked the U.S. Food and Drug Administration to expedite its approval process for a replacement foam for respiratory devices affected by the Philips recall.  “We are requesting accelerated approval from the FDA for this critical replacement component for approved technicians to rapidly start the process of replacing/repairing all recalled units,” states VGM in a letter to the agency.  Philips on June 14 announced a voluntary recall of certain...

WASHINGTON - The U.S. Food and Drug Administration warned consumers not to use oxygen concentrators in their homes unless prescribed by a health care provider in a consumer update posted to its website on Oct. 30 as the number of cases of COVID-19 spikes across the country. The agency says giving yourself oxygen without talking to a doctor first may do more harm than good. “You may end up taking too much or too little oxygen,” it says. “Deciding to use an oxygen concentrator without...

WASHINGTON - The U.S. Food and Drug Administration has issued a safety communication informing patients and health care providers that devices to clean, disinfect or sanitize CPAP devices or accessories using ozone gas or ultraviolet light are not legally marketed for this use by the FDA, so their safety and effectiveness is unknown. The FDA has identified several manufacturers that are marketing ozone gas or UV light-based products and asked them to submit data demonstrating their safety and effectiveness....

BRISBANE, Australia - Oventus Medical has received regulatory clearance from the U.S. Food and Drug Administration for its O2Vent Optima oral device to treat obstructive sleep apnea. “We are thrilled to have received FDA clearance, which enables us to sell the O2Vent Optima in the U.S.—a core market for Oventus, alongside Canada and Australia,” said CEO Dr. Chris Hart. “We look forward to officially launching our material agreements within U.S. sleep channels and working with...

ELYRIA, Ohio - Invacare has the green light to make and sell products again from its Taylor Street manufacturing facility and corporate headquarters here, the company announced July 25.A consent decree with the U.S. Food and Drug Administration has limited Invacare's ability to make and sell products from the facilities for nearly five years, since December 2012.“Invacare can design, manufacture, process, pack, repack, label, hold, distribute, import into or export from the United States, the...

ELYRIA, Ohio - Invacare reported $231.7 million in net sales for the first quarter of 2017, a 10% decrease compared to the same quarter last year. For its North America/HME business segment, Invacare reported $119.5 million in net sales for the first quarter, a 2.1% decrease. The company says net sales declines for North American/HME were due to the discontinuation of certain product categories and lower sales of respiratory products. It also noted that it discontinued sales of consumer power wheelchairs...

ELYRIA, Ohio - Invacare has completed the final milestones required to lift a consent decree with the U.S. Food and Drug Administration, paving the way for a re-inspection, the company announced April 27.“The re-inspection is an important step before the company may resume full operations at the impacted facilities,” Invacare stated in a press release.The decree has limited Invacare's ability to manufacture and sell certain products from its corporate headquarters and Taylor Street facilities...