The Magazine for Sleep Professionals
Friday, August 28, 2026
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 […]
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: SafeStar 55 Breathing System Filter Product Model Numbers: MP01790 Lot Number: LT2103 Devices Recalled in the U.S.: 35,950 Dates distributed: […]
The American Thoracic Society applauds the FDA’s decision to remove Juul products from the U.S. marketplace. This decision is long overdue. “Juul is one of the most popular e-cigarette products among middle and high school kids,” said Hasmeena Kathuria, MD, chair of the ATS Tobacco Action Committee. “Their flavored products are particularly […]
Nyxoah SA announced that the U.S. Food and Drug Administration (FDA) has approved the use of Nyxoah’s next-generation Genio® 2.1 system for use in the Company’s DREAM U.S. IDE pivotal study. Genio® 2.1’s upgrades are entirely related to the external components of the Genio® system, as the implantable stimulator remains […]
LivaNova PLC has announced the first patient implanted in the investigational device exemption (IDE) clinical study, “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation” (OSPREY). The randomized controlled trial (RCT) seeks to demonstrate the safety and effectiveness of the LivaNova aura6000™ System, an implantable hypoglossal neurostimulator intended to treat adult patients with […]
WatchPAT® with SleePATh® is a digital solution for clinicians which integrates automated subjective patient data with the WatchPAT® ONE home sleep study results for enhanced diagnosis, data management and analysis. It simplifies the patient journey, streamlines the clinical experience and enhances the diagnosis. It combines pre and post sleep study […]
Turn Medical has launched its first product, a prone positioning device, the Pronova-O2™ Automated Prone Therapy System. Substantial research has demonstrated the benefits of prone positioning for critically ill patients with respiratory distress. The Pronova-O2™ System provides an effective and efficient way for clinicians to move patients into the prone position and maintain […]
Masimo has announced Dual SET® Pulse Oximetry for Root®, a highly versatile patient monitoring and connectivity hub. The first application of Dual SET® Oximetry is a significant advancement to Masimo SET®-guided critical congenital heart disease (CCHD) screening, with the CE marking and European launch of the Masimo SET® MOC-9® module and the addition of […]
SoClean Inc. has filed a federal lawsuit in the United States District Court for the District of Massachusetts against Philips. According to the complaint, Philips has misled the public and engaged in acts of deliberate misdirection, placing blame on SoClean to divert attention away from obvious design flaws, including a poor choice […]
