Tag: Food & Drug Administration (FDA)
FDA approves GLP-1 for OSA
December 23, 2024HME News Staff
WASHINGTON – The U.S. Food and Drug Administration announced Dec. 20 that it has approved Zepbound (tirzepatide) for the treatment of moderate to severe sleep apnea in adults with obesity to be used in combination with a reduced-calorie diet and increased physical activity.
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Sally Seymour, M.D., director of the Division of Pulmonology, Allergy, and Critical...
Withings receives clearance for smart BPM
December 17, 2024HME News Staff
BOSTON – Withings Health Solutions, the professional health care division of Withings, has announced that its BPM Pro 2, a cellular blood pressure monitor that integrates and automates many aspects of clinical workflows, is now cleared by the U.S. Food and Drug Administration. The BPM Pro 2 is now cleared to measure blood pressure and pulse rate in adults with arm circumferences of nine to 17 inches or 16 to 20 inches. “We are thrilled BPM Pro 2 is now FDA-cleared, this device marks a...
Senseonics, Ascensia launch one-year CGM system
September 17, 2024HME News Staff
GERMANTOWN, Md., and PARSIPPANY, N.J. – Senseonics and Ascensia Diabetes Care have announced that the U.S. Food and Drug Administration has cleared the next-generation Eversense 365 CGM, the first one-year CGM system. “The approval of Eversense 365 represents a significant leap in CGM innovation,” said Tim Goodnow, PhD, president and CEO of Senseonics. “Extending sensor longevity to a full year, coupled with seamless device connectivity and a high level of accuracy, provides...
CPAP cleaners get warning
September 3, 2024HME News Staff
WASHINGTON – Four companies have received warning letters from the U.S. Food and Drug Administration for selling CPAP cleaning products without marketing clearance or approval, violating the Federal Food, Drug and Cosmetic Act.
The companies are:
Shenzhen Moyeah Intelligent Life Technology Co. for 10 different products, including the CPAP Cleaner With Sanitizer Bag Ozone Disinfector C966 or MOYEAH Brand New CPAP Sanitizer Bag Ozone Disinfector C966|Latest Technology.
Natures...
In brief: Numotion resolves allegations, AdaptHealth taps new exec, FDA strengthens oversight
August 28, 2024HME News Staff
PHOENIX, Ariz. – United Seating and Mobility, d/b/a Numotion, has agreed to pay $13.5 million to resolve allegations that the company violated the federal False Claims Act.
The settlement resolves allegations by the United States that Numotion submitted false claims to Medicare and other federal health care programs for custom wheelchairs and wheelchair parts. According to the allegations, the claims were false because they were based on patient evaluations that were unlawfully...
FDA to strengthen oversight of medical devices
August 26, 2024HME News Staff
WASHINGTON – The Food and Drug Administration has begun building a surveillance system to look for potential safety issues in medical products ranging from surgical masks to implantable pacemakers.
More than 1.7 million injuries and 83,000 deaths over a recent 10-year period in the U.S. have been potentially linked to faulty medical devices, according to a 2018 study by the Government Accountability Office.
Active postmarket surveillance involves the ongoing review of evidence—derived...
FDA grants auth to SoClean device
August 19, 2024HME News Staff
WASHINGTON – The U.S. Food and Drug Administration has granted a marketing authorization to SoClean for its SoClean 3+ bacterial reduction device for use with CPAP accessories (two hoses ResMed ClimateLine Air tubing and SlimLine tubing) and one mask (ResMed Mirage FX mask) for the ResMed AirSense 10 CPAP device. The SoClean 3+ does not replace the cleaning steps recommended by manufacturers of CPAP devices. To date, there are no FDA cleared or approved devices for cleaning, disinfecting or...
FDA to launch Home as a Health Care Hub
May 16, 2024HME News Staff
WASHINGTON – The U.S. Food and Drug Administration is launching Home as a Health Care Hub, an initiative to help reimagine the home environment as an integral part of the health care system, with the goal of advancing health equity for all people in the U.S. The initiative will serve as an idea lab, not only to connect with populations most affected by health inequity, but also for medical device developers, policy makers and providers to begin developing home-based solutions that advance health...
Senators urge GAO to review FDA oversight of recalls
December 14, 2023HME News Staff
WASHINGTON – U.S. Senate Majority Whip Dick Durbin, D-Ill., and U.S. Sen. Richard Blumenthal, D-Conn., have sent a letter to the Government Accountability Office (GAO) calling on the agency to update its 2011 report entitled “Medical Devices: FDA Should Enhance Its Oversight of Recalls” in the wake of the Philips Respironics recall.
The Senators sent the letter following the Pittsburgh Post-Gazette’s and ProPublica’s reporting on the recall of certain...
FDA updates Philips report count
June 6, 2023HME News Staff
AMSTERDAM – The U.S. Food and Drug Administration received more than 6,000 medical device reports (MDRs) associated with the PE-PUR foam degradation in certain recalled Philips CPAP and BiPAP machines and ventilators from Jan. 1, 2023, through March 31, 2023, including 40 reports of death. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. A wide range of injuries have been reported in these MDRs, including...