Skip to Content

Tag: FDA


Frans van Houten

Vendors

Philips says updates are ‘imminent’

July 27, 2021Liz Beaulieu, Editor

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...

CPAP Devices, FDA, Foam, Philips Recall, ventilators


Read Full Articlered right arrow icon

News

Philips recall: VGM asks FDA to speed up approval

July 22, 2021HME News Staff

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...

FDA, Philips Recall, VGM


Read Full Articlered right arrow icon

News

FDA on oxygen concentrators: Don't try them at home without scripts

November 4, 2020HME News Staff

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...

FDA, Oxygen Concentrator


Read Full Articlered right arrow icon

Also Noted

FDA issues safety communication on CPAP cleaning devices

March 11, 2020HME News Staff

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....

Cleaning, CPAP, FDA, safety communication, sanitizing


Read Full Articlered right arrow icon

Also Noted

Oventus ready to hit US market with oral device

September 6, 2019HME News Staff

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...

FDA, Oral device, Oventus Medical, Sleep Apnea


Read Full Articlered right arrow icon

Vendors

FDA lifts Invacare's consent decree

July 25, 2017HME News Staff

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...

Consent Decree, FDA, Invacare, wheelchair


Read Full Articlered right arrow icon

Also Noted

Invacare sets stage for cost reductions

May 9, 2017HME News Staff

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...

Earnings, FDA, Invacare


Read Full Articlered right arrow icon

Vendors

Invacare clear for re-inspection

April 28, 2017HME News Staff

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...

Consent Decree, FDA, Invacare


Read Full Articlered right arrow icon

Specialty Providers

FDA expands approval for CGM system

December 23, 2016HME News Staff

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...

Continuous Glucose Monitoring, Dexcom, FDA


Read Full Articlered right arrow icon

Also Noted

FDA approves artificial pancreas system

September 29, 2016HME News Staff

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...

Artificial Pancreas System, FDA, JDRF


Read Full Articlered right arrow icon