The Magazine for Sleep Professionals
Wednesday, April 8, 2026
Program update As we approach the end of 2022, we expect to complete around 90% of the production this year for the delivery of replacement devices to patients. Patients who are still waiting to receive their replacement device can expect to continue hearing from us as we work through some […]
React Health has announced 510(k) clearance by the U.S. Food and Drug Administration for the Luna G3 Bilevel S/T 30VT as a non-invasive ventilator. This expands the utilization of the device beyond the sleep-disordered breathing space into management of chronic respiratory conditions. “We are pleased that the FDA has approved […]
Transcend Inc. recently introduced Transcend Micro, the world’s smallest and lightest portable continuous positive airway pressure (CPAP) device. Weighing under a half pound and measuring less than four inches, Transcend Micro is designed to make it more convenient for people who suffer from Obstructive Sleep Apnea to maintain their sleep […]
By Nathan Costiuc, MSN, APRN, FNP-BC There is a burden that sleep clinicians carry with them in any patient encounter – the burden of knowing that the results of your work with patients suffering from obstructive sleep apnea (OSA) depend heavily on how well those patients adhere to treatment. Unfortunately, […]
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. The […]
Nihon Kohden OrangeMed, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NKV-330 Ventilator System. The NKV-330 is a non-invasive ventilator that provides respiratory support to adult and pediatric patients. It offers not only non-invasive ventilation but also invasive ventilation as well as high-flow oxygen therapy. In […]
Testing in accordance with ISO 18562 and ISO 10993 standards conducted by five certified, independent testing laboratories in the US and Europe This update is intended to provide healthcare providers, patients, and other stakeholders with updated information on the testing results to date. Philips will continue to provide regular updates as new […]
In June 2021, Philips Respironics, initiated a voluntary recall notification in the US/field safety notice in other countries for certain sleep and respiratory care products to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in certain CPAP, BiPAP and mechanical ventilator devices. At the time the […]
With a grant from the National Institute of Science, Eclipse™ will launch late in the third quarter of 2022. Eclipse uses MagSeal™ technology to ensure a rapid on/rapid off interface. Like the DreamPort also by Bleep, Eclipse™ optimizes PAP users comfort by removing all of the headgear and straps and […]
The FDA’s Center for Devices and Radiological Health is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act, to require Philips Respironics (“Philips”) to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices […]
