The Magazine for Sleep Professionals
Friday, August 28, 2026
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) […]
The FDA announced its decision to “prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars.” In response, the American Thoracic Society issued the following statement: “The ATS strongly supports the FDA proposed action to remove menthol-flavored cigarettes and flavored cigars from the U.S. marketplace,” said Hasmeena Kathuria, MD, ATS Tobacco […]
Pfizer Inc. announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older. The FDA decision is primarily […]
Idorsia Pharmaceuticals, US Inc. has announced that the US Food and Drug Administration (FDA) has approved QUVIVIQ™ (daridorexant) 25 mg and 50 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance1. The FDA approval of QUVIVIQ is based on an extensive […]
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 […]
