The Magazine for Sleep Professionals
Sunday, September 20, 2026
SleepOvation Baby, an FDA-registered manufacturer of medical devices 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 listing […]
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) […]
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 […]
The FDA’s Center for Devices and Radiological Health is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act, to require Philips Respironics (“Philips”) to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices […]
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 […]
“The ATS reiterates our long-held position – e-cigarettes are not “safe” and the claims that e-cigarettes are a harm reduction tool remain unproven. All e-cigarettes have significant health risks including nicotine addiction and respiratory disease,” said ATS President Lynn Schnapp, MD, ATSF. The ATS notes that the FDA has finally issued decisions […]
