The Magazine for Sleep Professionals
Sunday, November 1, 2026
Sunrise, announced the U.S. Food and Drug Administration (FDA) has cleared for use of its second-generation at-home sleep apnea test that uses artificial intelligence (AI) to aid in the diagnosis of obstructive sleep apnea and sleep-related breathing disorders. The Sunrise team is using a novel way to measure sleep through […]
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) […]
Onera Health announced that its wholly owned subsidiary in the Netherlands, Onera B.V., has received 510(k) market clearance from the U.S. Food & Drug Administration (FDA) for its ground-breaking system for Polysomnography (PSG) studies, Onera STS, paving the way for widespread deployment of the patch-based technology across healthcare systems in […]
Sound Life Sciences, a pioneer in contactless respiratory monitoring with its proprietary sonar software for consumer smart devices, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The privately-held telehealth startup’s smartphone or smartspeaker app produces inaudible ultrasonic sonar pulses to detect reflections caused […]
AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnea (OSA) in adults, has obtained FDA 510(k) clearance as a Class II medical device in the USA. The device, developed and commercialized by UK-based medical device company Acurable, builds on more than ten […]
ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced that the Food and Drug Administration (FDA) has granted the Company De Novo clearance for the Hemolung Respiratory Assist System. The Hemolung System is the first and only […]
GE Healthcare announced it has received Food and Drug Administration (FDA) 510(k) clearance for an artificial intelligence (AI) algorithm to help clinicians assess Endotracheal Tube (ETT) placements. The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on […]
Nyxoah SA has announced that the U.S. Food and Drug Administration has granted the Genio® bilateral hypoglossal nerve stimulation system Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate. The FDA’s Breakthrough Designation Program was created […]
EnsoData announces its FDA 510(k) clearance of new capabilities and enhancements to its product EnsoSleep, a leading AI-assisted sleep scoring solution. With a substantial clinical study size, EnsoSleep’s validation metrics support diagnostic accuracy, helping sleep labs and healthcare systems provide care more efficiently and improve patient outcomes across the globe. […]
Getinge announces clearance from the FDA of several new software options for the Servo-u and Servo-n ventilators. In addition to the latest software upgrades, Getinge also received clearance for the new Servo-u MR ventilator for the MRI room. “The COVID-19 pandemic and the heightened awareness of respiratory health have driven […]
