The Magazine for Sleep Professionals
Thursday, April 16, 2026
Obstructive sleep apnea (OSA) is a complex condition with a variety of contributing anatomical, physiological, inflammatory, and obesity-related risk factors, which can lead to many physiological changes in the body.1 Yet for patients with OSA, there is good reason to be hopeful right now. We are witnessing tremendous advances in […]
Resmed announced its home sleep apnea test, NightOwl™, is now available across the United States. NightOwl is an FDA-cleared home sleep apnea test (HSAT) designed to offer healthcare providers a simplified, accurate, and efficient way to diagnose obstructive sleep apnea (OSA) from the comfort of an individual’s home. OSA, a […]
Avadel Pharmaceuticals plc , a biopharmaceutical company focused on transforming medicines to transform lives, announced that yesterday, the U.S. District Court for the District of Columbia (“Court”) ruled in favor of the Food and Drug Administration (“FDA”) in a suit brought by Jazz Pharmaceuticals Inc. (“Jazz”) under the Administrative Procedure […]
Centessa Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) to initiate a Phase 1 first-in-human clinical trial of ORX750 for the treatment of narcolepsy. ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist […]
Inspire Medical Systems, Inc. announced that it has received approval from the Food and Drug Administration (FDA) on an expanded indication. The update includes an increase on the upper limit of the Apnea-Hypopnea Index (AHI) to 100 events per hour from 65 and raises the Body Mass Index (BMI) warning […]
Inspire Medical Systems, Inc. announced today that it has received approval from the Food and Drug Administration (FDA) to offer Inspire therapy to pediatric patients with Down syndrome. “Since our first FDA approval in 2014, the research team at Mass Eye and Ear, led by Dr. Christopher Hartnick, have pioneered […]
Belun Technology has just received FDA 510(k) clearance from the US Food and Drug Administration (FDA) for its Belun Sleep System as the world’s first wearable ring for obstructive sleep apnea (OSA) using AI. Belun Sleep Platform, which is comfortable and easy to use, is believed to speed up the […]
SleepOvation Baby, an FDA-registered manufacturer of medical devices, today announced that its crib mattress has been listed by the FDA for sale. With this listing, parents can shop with confidence knowing that SleepOvation Baby’s crib mattress is safe and effective for babies. “SleepOvation Baby is thrilled to obtain this FDA […]
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 […]
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) […]
