Tag: FDA

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...

SAN DIEGO - Dexcom has received expanded approval from the U.S. Food and Drug Administration for the G5 mobile continuous glucose monitoring system.This is the first FDA-approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation from a traditional fingerstick test. The system was previously approved to complement, not replace, fingerstick testing for diabetes treatment decisions.“This may allow some patients to manage their disease...

NEW YORK - The Food and Drug Administration has approved a commercial version of the Medtronic MiniMed 670G hybrid closed-loop system, an artificial pancreas system. "This announcement is a historic achievement for JDRF,” said Derek Rapp, CEO of the nonprofit dedicated to funding type 1 diabetes research. “After years of laying the ground work, this breakthrough is a testament to the reason JDRF exists—to help people with Type 1 diabetes lead better, safer, healthier lives while...

WASHINGTON - CMS has endorsed the use of unique device identifiers in billing records for medical devices, according to the Wall Street Journal. The ID numbers have been advocated by lawmakers and the U.S. Food and Drug Administration for years, but never by Medicare. The idea: Because the ID numbers would appear in databases of hospitals and big insurers, including Medicare, they would help the FDA to quickly find malfunctioning devices and order a recall if necessary, the Journal reports. CMS Acting...

ELYRIA, Ohio - Invacare has hit a bump in the road in its goal of lifting a consent decree with the Food and Drug Administration that has handicapped the company since late 2012.Invacare previously reported in February of this year that an independent auditor had issued a certification report for the third and final phase of the decree. The company planned to submit its own report and seek approval for both reports from the FDA.On June 7, however, Invacare received a letter from the FDA outlining...