The Magazine for Sleep Professionals
Saturday, October 31, 2026
Rhythmlink International, LLC has announced FDA clearance of a new product line. Sticky Pad™ Surface Electrodes, a line of peel and stick-on electrodes for Intraoperative Neurophysiological Monitoring (IONM) and Electroencephalography (EEG) are now FDA Cleared MR Conditional for 1.5 and 3 Tesla MRI environments. Rhythmlink has been selling a line […]
3B Medical, Inc. has received FDA 510(k) clearance on its new third-generation bi-level device, the Luna G3 Auto-BPAP. The Luna G3 Auto BPAP is a modern and technologically advanced Bi-Level PAP therapy device for the treatment of obstructive sleep apnea. This device is available with integrated heated tubing, cellular connectivity […]
US Food & Drug Administration (FDA) clears Servo-air® mechanical ventilator for use with adult and pediatric patients dependent on intensive care ventilation, expanding upon the Servo family of products available in the United States for decades. “FDA 510(k) clearance for Servo-air will broaden our US offering with a turbine-driven ventilator,” says Eric […]
Fisher & Paykel Healthcare Corporation Limited announced that F&P Evora™, a nasal mask for the treatment of obstructive sleep apnea (OSA) has received regulatory clearance for use in the United States. F&P Evora is a compact nasal mask that sits comfortably under the nose. The mask features CapFit™ headgear, which […]
Masimo announced that Centroid™, a wearable, wireless patient orientation, activity, and respiration rate sensor, has received FDA clearance. Centroid helps clinicians monitor patient position to avoid preventable pressure ulcers, and can alert clinicians to sudden movements such as fall-like events. In addition, Centroid detects chest movements to continuously provide respiration […]
Harmony Biosciences, LLC (Harmony) announced yesterday that FDA approved WAKIX®(pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. WAKIX is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA). […]
TherOx, Inc. has received premarket approval for its SuperSaturated Oxygen (SSO2) Therapy. SSO2 Therapy provides interventional cardiologists with the first and only FDA approved treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage in heart attack patients. SSO2 Therapy delivers hyperbaric levels of oxygen directly to the ischemic […]
Masimo announced FDA clearance of the Rad-67™ Pulse CO-Oximeter® with Spot-check Next Generation SpHb® monitoring technology and the rainbow® DCI®-mini Reusable Sensor. Rad-67 offers rainbow® noninvasive hemoglobin measurement (SpHb) and Measure-through Motion and Low Perfusion™ SET® pulse oximetry in a compact, portable spot-check monitoring device. When used with the rainbow® DCI-mini sensor, Rad-67 provides spot-check monitoring […]
Instrumentation Laboratory (IL) announced the 510(k) clearance of their latest innovation, the GEM Premier ChemSTAT in vitro diagnostic (IVD) analyzer with Intelligent Quality Management (iQM®) by the US Food and Drug Administration (FDA). A new and complementary member of the GEM® Premier™ Family, the GEM Premier ChemSTAT system is designed for […]
Olympus announced the market availability of its FDA-approved Spiration Valve System (SVS) for the treatment of severe emphysema, a progressive form of Chronic Obstructive Pulmonary Disease (COPD). Prominent guidelines1,2, now recommend minimally invasive bronchoscopic lung volume reduction using endobronchial valves as an alternative treatment option for severe emphysema to more […]
