The Magazine for Sleep Professionals
Friday, October 9, 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 […]
Dräger, an international medical and safety technology leader, announced that Frost & Sullivan has selected the company for its 2022 Global New Product Innovation Leadership Award in neonatal and respiratory care categories. Dräger was the recipient of Frost & Sullivan’s Global Technology Innovation Leadership Award for mechanical ventilation in 2014, […]
Bedfont Scientific Ltd., is celebrating a brighter 2022 as the U.S. Food and Drug Administration (FDA) cleared its NObreath FeNO monitor for use in monitoring airway inflammation. The NObreath®, which conforms to ATS and ERS guidelines1, is a portable, non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) […]
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 […]
ProSomnus, a leader in patient-preferred medical devices for the treatment of Obstructive Sleep Apnea (OSA), today announced the results of three studies evaluating its FDA-cleared Oral Appliance Therapy (OAT) devices in the treatment of OSA. ProSomnus will share data in three poster presentations at SLEEP 2022, the Annual Meeting of […]
SleepRes, LLC introduces the V̇-Com™ at SLEEP2022/APSS this week, a revolutionary device to make CPAP more comfortable and increase adherence. The V̇-Com™, which softens peak inspiratory flow, makes starting CPAP easier and faster. “This may be the most important comfort factor in the PAP circuit since we developed BiPAP over […]
According to MediPines, an increasing number of physicians have been utilizing a unique gas exchange analyzer technology to enhance recognition and diagnosis of pulmonary embolism (PE) in patients. The device, called the MediPines AGM100, is an FDA-cleared advanced pulmonary gas exchange technology that can precisely and non-invasively measure patients’ oxygen and […]
