SAN DIEGO, California—Resmed, a health technology company focused on sleep, breathing and care delivered in the home, announced its home sleep apnea test, NightOwl, is now available across the United States. NightOwl is an FDA-cleared home sleep apnea test (HSAT) designed to offer health care providers a simplified, accurate and efficient way to diagnose obstructive sleep apnea (OSA) from the comfort of an individual’s home.
NEW YORK—The New York City Council voted to establish a sleep apnea screening pilot program. The program will seek to expand access to preventive medical care and improve health outcomes by providing screenings to New Yorkers at no cost, prioritizing individuals without insurance.
LONDON—Signifier Medical Technologies Limited, which makes medical technology for sleep-disordered breathing, today announced the introduction of its newest SKU, 18010, which features a hardware remote control specifically designed to meet Centers for Medicare & Medicaid Services (CMS) requirements for reimbursement. The company said this development means eXciteOSA therapy can be more readily accessed by Medicare and Medicaid patients.
LOS ANGELES—Amino Health, a digital health care guidance platform, announced a partnership
PETERBOROUGH, New Hampshire—SoClean, a bacterial reduction system for continuous positive airway pressure (CPAP) hoses and masks, announced its “SoClean 3+” equipment has been granted de novo clearance by the Food and Drug Administration (FDA). The SoClean 3+, an at-home cleaning device for CPAP hoses and masks, is the only FDA-cleared product intended to reduce bacterial populations on compatible masks and ventilation hoses.
IRVINE, California—Fisher & Paykel Healthcare Corporation Limited announced the launch of the F&P Solo Nasal mask in the U.S. for the treatment of obstructive sleep apnea (OSA).
What Fisher & Paykel said is the world’s first AutoFit mask, F&P Solo, simplifies setup, enabling users to stretch the mask onto the face and adjust it with one touch.
RIDGEFIELD PARK, New Jersey—Samsung Electronics Co., Ltd. announced that the sleep apnea feature1 on the
SAN DIEGO, California—ResMed launched its AirCurve 11 series devices, the company’s newest bilevel devices that use two levels of support, inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP), combined with digital technology to make it easier for health care providers to treat sleep apnea and to help patients start and stay on therapy.
LITTLETON, Colorado—Vivos Therapeutics, Inc. (the “company” or “Vivos”) a medical technology company focused on developing innovative treatments for patients suffering from mild-to-moderate obstructive sleep apnea (OSA) and snoring in adults, has signed a U.S. nationwide distribution agreement with Lincare, a leading supplier of in-home respiratory therapy products and services for approximately 1.8 million patients.
CAMBRIDGE, Mass. (October 18, 2022)—Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies to treat obstructive sleep apnea (OSA) and related disorders, announced positive topline results from the MARIPOSA Phase 2b trial, an efficacy, safety and dose-finding study of one-month duration.
MONTGOMERY, Ala. (July 14, 2022)—Last week, Alabama Medicaid announced that CPAP and BiPAP devices will be billed as a “straight purchase,” ending the rental period payment process for this equipment. The agency also announced the waiver of the compliance requirement for CPAP and BIPAP devices and updated allowable quantities for PAP supplies. The new measures go into effect Aug. 1, 2022.
PHOENIX (March 29, 2022)—Fisher & Paykel Healthcare (F&P) will be showing off its wares at Booth #621 at Medtrade West, scheduled to begin on Monday, April 4 at the Phoenix Convention Center. The Auckland, New Zealand-based F&P recently reported that the company expects full year operating revenue for the 2022 financial year to be in the range of $1.675 billion to $1.70 billion.
PHILADELPHIA (March 24, 2022)—Philips was hit with a potential class action last week by a medical device retailer claiming it and others are owed a refund due to lost money because they were unable to resell Philips' CPAP and BiPAP breathing machines, which contained PE-PUR foam.
AN DIEGO (March 15, 2022)—ResMed announced the results of its 2022 Global Sleep Surveys, in conjunction with National Sleep Awareness Week (March 13-19) and World Sleep Day (March 18). The surveys, conducted in the first quarter of the year, asked nearly 25,000 respondents in 12 countries what’s keeping them up at night and the results aim to build awareness of the critical role good sleep plays in physical and mental health.
BIRMINGHAM, Ala. (November 16, 2021)—During a recent plant inspection, the Food & Drug Administration (FDA) found that silicone-based foam Philips Respironics planned to use to repair recalled CPAP and ventilator devices had failed a safety test for volatile organic compounds.
DEERFIELD BEACH, Fla. (November 5, 2021)—As America prepares to observe Veterans Day in honor of those who served, fought and died for us, AirAvant Medical and First Nation Group announce a partnership alliance providing the FDA-cleared Bongo Rx Expiratory Positive Airway Pressure (EPAP) device to vterans and active-duty military members suffering from obstructive sleep apnea (OSA).
PORT WASHINGTON, N.Y. (September 1, 2021)—Drive DeVilbiss Healthcare announced today the discontinuation of the DV5 and DV6 series CPAP devices as of December 2021. As a result, Drive DeVilbiss will no longer accept new CPAP orders in order to fill as many open orders as possible.
AMSTERDAM (September 1, 2021)—Royal Philips today announced an update in connection with the June 14, 2021 recall notification for specific Philips sleep and respiratory care devices that was issued to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. More than half of the affected devices in use globally are in the United States. The vast majority (>80%) of the registered affected devices in the U.S.
